The Holy Grail … is in Oz?

I am delighted to be involved in Apollo’s research on oral delivery of proteins, with potential application for insulin. Diabetes is growing at an alarming rate worldwide and will probably be the largest epidemic Australia has ever experienced. The potential to deliver insulin orally has always been a high priority in diabetes research - it has been considered the ‘holy grail’ of diabetes treatment…..

…Professor Paul Zimmet AO –probably Australia’s top Diabetes authority.

Professor Paul Zimmet currently holds the following positions:-
• Professor/Director, International Diabetes Institute
• Professor of Diabetes, Monash University
• Professor (Hon), University of Pittsburgh (USA)
• Professor (Hon), Deakin University, Victoria
• Head, World Health Organization Collaborating Centre for the Epidemiology of Diabetes

Putting an end to injections is one of the great aims of diabetes research, and biotech companies are scrambling to tap into a market worth billions of dollars. An insulin tablet that could potentially revolutionise treatment is scheduled to begin human trials in Australia later this year, testing technology developed by Sydney-based Apollo Life Sciences to overcome hurdles that currently require insulin to be injected.

Apollo is one of several companies around the world developing oral insulin products to replace needles. Sprays and powders that can be absorbed through the lungs or walls of the cheeks are being tested overseas, but Apollo is keen to pursue an insulin tablet, which patients may find preferable.

The tablet needs to beat two key barriers: insulin is destroyed by acids in the stomach unless protected, but any protective shield hampers its absorption into the bloodstream through the gut wall.

This month, Apollo filed a patent application for its Oradel technology, which it believes will solve both problems. The insulin is encapsulated in a tiny “transporter molecule” to protect it, which is then coated with a vitamin.

Vitamins are naturally pulled through the stomach wall into the bloodstream, taking the molecule through as well. It then breaks down, releasing the insulin.

Apollo chief executive John Priest says the technology has been impressive in animal tests. “In our pre-clinical studies, the oral insulin has performed exceedingly well. It has taken insulin down to normal levels in diabetic animals and been able to hold it there for eight to 24 hours,” Priest says. “The end result of that is a tablet a day.”

Apollo has appointed three experts from the International Diabetes Institute to an advisory committee: Professor Paul Zimmet, Associate Professor Jonathan Shaw and Dr Matthew Cohen. Zimmet says the very early data indicates Apollo’s method is one of the best prospects for developing oral insulin.

Dr Neville Howard, president of Diabetes Australia (NSW), says diabetics and doctors will welcome oral insulin but warns it has proven difficult to develop. “[Researchers] have been trying to develop oral insulin for a long time and most have fallen over because insulin is unique in hormones; the dosage has to be very precise,” he says.

“Too much is dangerous and too little doesn’t work. That has been a problem for at least two decades for researchers trying to get oral insulin.”

Professor Lesley Campbell, a clinician and diabetes researcher at the Garvan Institute, agrees a tablet may not be sophisticated enough to get dosages and regulation of insulin right, for example after meals. “Regulation of insulin therapy is the real challenge,” she says.

If those barriers can be overcome, the financial returns are likely to be substantial. “Currently, for all diabetes and for all treatments, the market is around $US18bn a year annually and it’s growing at 40% per annum, which is a bit staggering really,” says Priest. “Doctors are loathe to prescribe and people are loathe to use needles and so tend not to control their diabetes as well as they might. This will take that problem away.”

While newer insulin products are used for injection, Priest says older versions of insulin can be used for the tablets, making it “cheap and easy and scalable to make”.

Apollo plans to use the Oradel technology in trials of its anti-inflammatory therapy, which it hopes can replace injections for serious cases of conditions including arthritis and Crohn’s disease. It’s also working on ways to have molecules absorbed through the skin. This year, it announced it had successfully vaccinated mice against tetanus this way.

The insulin tablets will be the first of Apollo’s drugs to go into clinical trials. Priest expects to reach phase two in the next 18 months; faster than a typical trial because the delivery system, not the drug, is being tested. Apollo will then seek a development partner for larger, more expensive trials.

Folks.  You heard it here first!

Technorati Tags: Alternative Diabetes Treatment, Appollo, Delivery of oral Insulin, Diabetes treatment break through, Diabetes Treatments, New Diabetes Treatment, Oral Insulin, Paul Zimmet AO

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Friday, July 6, 2007

Quo Vadis Avandia?

While I spent three weeks in hospital for bone
graft surgery - it seemed every week there was 
a new twist to the Avandia plot that makes it 
more and more of a soap opera!

It all started with the publication of a study in the May 21, 2007 online version of The New England Journal of Medicine by Steven Nissen. The study stated that people taking Avandia® have a 43 percent greater chance of developing myocardial infarction compared to people not taking Avandia®, and a 64 percent greater chance of death from cardiovascular causes. Nissen stated, “… patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with [Avandia®,] for type 2 diabetes.”

The FDA quickly followed suit by issuing a safety alert on Avandia®.

As a long term user of Avandia – over a decade – I avidly read….

Avandia Maker Goes on the Defensive
GlaxoSmithKline, which manufactures Avandia®, quickly went on the defensive issuing a statement saying it “strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.”

A few weeks later, GlaxoSmithKline reported an interim analysis of RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes) — a prospective clinical trial designed specifically to determine cardiovascular outcomes in more than 4,400 patients with type 2 diabetes. The study, which is scheduled to be completed in June 2008, compares cardiovascular hospitalization and death in patients treated with Avandia® dual therapy (Avandia® plus metformin or sulfonylurea) and in patients treated with metformin and sulfonylurea in combination. After following patients for an average of 3.75 years, the interim analysis found a low number of events overall, and a similar number of events in each group. GlaxoSmithKline claims that the interim findings of the RECORD trial, which were published in the June 5, 2007 online edition of The New England Journal of Medicine, adds further evidence to the overall cardiovascular safety profile of Avandia ®. 

That warmed my heart! [and protected it?]

Only a Hypothesis –more support….

John Buse, MD, PhD, is professor of medicine at the University of North Carolina School of Medicine. Buse says that the Nissen paper published in NEJM generates a hypothesis, but does not generate proof of any issues whatsoever.

“Meta-analysis is not designed to answer questions just to raise them,” says Buse. “That said: it raises an important question. The RECORD study is designed to provide proof, but this is an interim analysis so we don’t have the full result. The balance between the two, frankly, doesn’t tell us much. So, a concern has been raised about particular cardiovascular issues and what the RECORD study tells us is that the concern could be valid or invalid. But the answer isn’t there.”

I felt even better! Till I read Tanenberg….

Robert J. Tanenberg, MD, FACP is a professor of medicine at East Carolina University and director of the Diabetes and Obesity Centre. He states that there are alternatives to Avandia, but other than insulin, many are not as effective for controlling glucose.

Eliminating TZDs Would Be ‘Disastrous’

Tanenberg says that he will not be writing any new prescriptions for Avandia®. He is currently changing concerned patients on Avandia® to Actos®. His main concern is that both drugs may eventually be taken off the market.

“Unfortunately, until the drug is vindicated, there will continue to be patient concerns and possibly liability for prescribing it,” he says. “In medicine, the first rule is to ‘do no harm,’ so when there is a drug in controversy and I have a good alternative, I will most likely not prescribe a potentially harmful drug.”

David Kliff, publisher of the Diabetic Investor, he is not very optimistic that anything good will come out of the Avandia® drama.

“From a business perspective, we already know that GlaxoSmithKline is taking a beating,” says Kliff. “I think Takeda [which manufactures Actos—another TZD drug like Avandia] is also in a difficult situation because of guilt by association.”

Kliff’s personal opinion is that the FDA will put black-box warnings on both Avandia® and Actos®, and ask both GlaxoSmithKline and Takeda to do further, long-term clinical trials.

“In effect, this will kill [Avandia® and Actos®] in the marketplace,” says Kliff. “Because once the black-box warning goes on, the physicians who are already worried about being sued for using the drug will never prescribe them. Why take the chance when you have options like metformin, sulfonylureas and insulin.”

Buse says if the fallout continues and Avandia® — and even Actos® — are removed from the market — essentially eliminating the TZD class of drugs— it would be disastrous.”

“Clearly, more people would be harmed from withdrawing both Avandia® and Actos® than could possibly benefit,” says Buse. “The reason for that is that, in my experience, and, to some extent with some support from the literature, you just cannot control the average patient with type 2 diabetes with any combination of drugs as well as you can with [Avandia or Actos] plus insulin. There would be no substituting for it. You can use other drugs whose safety record is less well known, but, just at face value, there is no other class of insulin-sensitizing drugs, so you cannot replace that.”

There you have it – I promise to monitor the controversy daily now that I am back in my office …. And, continuing with my Avandia.

Technorati Tags: Actos, Avandia, GlaxoSmithKline, side effects of diabetes treatments, Takeda, treatements for type 2 diabetes, Treatment for diabetes, TZD

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Tuesday, July 3, 2007

A New BGL Monitor ….and More on Avandia

An update from Hi-Tech Harold…

The U.S. Food and Drug Administration Monday approved a device that measures glucose levels continuously for up to seven days in people with diabetes.

While a standard fingerstick test records a person’s glucose level
as a snapshot in time, the STS-7 Continuous Glucose
Monitoring System measures glucose levels every five minutes
throughout a seven-day period. The FDA said that additional
information can be used to track patterns in glucose levels
throughout the week that wouldn’t be captured by fingerstick
measurements.

However, diabetics must still rely on the fingerstick test to
decide whether additional insulin is needed, the FDA added.
The STS-7 System, manufactured by DexCom Inc. of San Diego
uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid found in the body’s tissues. Sensor placement causes minimal discomfort and can easily be done by patients themselves. An alarm can be programmed to sound if a patient’s glucose level reaches pre-set lows or pre-set highs.

A three-day version of the device was approved in March 2006.

More on the Avandia Discussion: Early Critic of Diabetes Drug Says Don’t Panic…

Patients should not haphazardly stop taking the controversial diabetes drug Avandia, even though it has been linked to heart risks, an early critic of the drug said on Sunday.
Dr. John Buse, chief of endocrinology at the University of North Carolina at Chapel Hill and incoming president of the American Diabetes Association, was one of the first experts to query the safety of GlaxoSmithKline’s blockbuster drug.

He raised questions about the drug’s heart safety in 2000.

But Buse told the Endocrine Society’s annual meeting in Toronto that he does not believe patients should stop taking the popular pill just yet.

“We’ll have additional data in the near future and that would be the appropriate time to consider making judgments over Avandia’s safety,” Buse told Reuters in an interview.
Buse also said he would tell the U.S. Congress this week about how GlaxoSmithKline may have tried to pressure him about his early criticism of the drug’s safety.

A clamour about Avandia, taken by millions of people, arose from consumer groups, heart experts and Congress last month after Cleveland Clinic cardiologist Dr. Steven Nissen’s pooled analysis was published in the New England Journal of Medicine.

Nissen’s study linked the diabetes drug to a 43 percent increased risk of heart attack and a 64 percent higher risk of any heart-related death.
The U.S. House of Representatives Oversight and Government Reform Committee has scheduled a hearing on the U.S. Food and Drug Administration’s handling of the drug, approved in 1999.

Buse said he would testify at that hearing.

TROUBLING QUESTIONS

The New York Times quoted University of Michigan diabetes expert Dr. Charles Burant as saying that Buse had been troubled by pressure he had received from Glaxo about his questions over the drug.

It quoted Burant as saying Glaxo had contacted University of North Carolina medical school.

Buse declined to give any more details of what happened, saying he would wait for the hearing. He characterized the issue as “ancient history.”

“If I am asked a question about it, I’ll answer it. I don’t have anything to hide,” he told Reuters.

Glaxo said it did have discussions with Buse. “We regret if, at any time, Dr. Buse felt the conduct of any GSK employee was contrary to the spirit of open, scientific debate regarding his views on Avandia,” the company said in a statement.

Glaxo has disagreed with the study findings and says Avandia is safe.

“If there is a safety problem with Avandia it needs to be taken off the market. There is no doubt about that,” Buse said.

“I still have concerns but I don’t think Dr. Nissen’s analysis has changed the landscape dramatically,” he added.

“Dr. Nissen’s study is adequate to raise the question. It’s just not adequate to provide the answer.”

Dr. Hertzel Gerstein, director of the division of endocrinology and metabolism at McMaster University in Ontario, Canada, agreed.

“My big concern of summarizing this type of data is that none of the trials that were summarized were designed to answer the question of whether the drug increases or reduces the risk of heart attack,” Gerstein said in an interview.

“For patients, this creates a lot of anxiety,” he added.

Stay with ODB for more news on Avandia.

Technorati Tags: Avandia and Diabetes, DexCom Inc, Diabetes and drugs, Diabetes Avandia debate, drugs and diabetes, living with diabetes, problems with Avandia, Risks with Avandia, STS 7 System

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Tuesday, June 12, 2007

Quo Vadis Avandia?

Let me preface these remarks with the disclosure that
I have been using Avandia for nearly a decade; and, have
been very happy with the results. I have yet to make up
my mind on its future use. I was a member of the original
 evaluation panel. I was shocked as anyone with the news
last week…………………………………………………….

James Montgomery.

GlaxoSmithKline’s widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert.

The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug.
GlaxoSmithKline’s stock fell sharply on the news.

More than six million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43% higher risk of heart attack, according to the review published by the New England Journal of Medicine.

Experts said the overall risk was small and cautioned people not to stop taking the drug on their own but to talk to their doctors.

The company strongly disputed the results, saying the analysis by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic is not definitive scientific proof. In a conference call, Dr. Lawson McCartney who leads Glaxo’s diabetes drug development, said the company is not seeing “anything like” the problems reported in the medical journal.
“We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine,” McCartney said.

The government will take no immediate action on a label change or other measures regarding the drug, said Dr. Robert J. Meyer of the FDA’s Center for Drug Evaluation and Research.

Some data suggests “that there is a potentially significant increase in the risk” but there also is risk if patients switch drugs or do not keep their blood-sugar under control, an FDA statement says.

FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm and said they would hold hearings on the safety issues.

Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to the article in the NEJM

May 21, 2007; the following is a Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to NEJM article, ‘Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes’:

Today the New England Journal of Medicine published an article entitled, ” Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The conclusions of this analysis of previous studies of rosiglitazone (brand name, Avandia) suggest that this oral agent used to treat type 2 diabetes may be associated with increased risk of heart attack and death from cardiovascular causes.

According to ACC, ADA and AHA, this study deserves serious thought and follow-up. As estimated here, the overall level of the risk associated with rosiglitazone appears to be small, but nonetheless one that must be considered carefully.

In the meantime, patients using this drug should talk to their health care provider to determine the most appropriate course of action. Patients should not stop taking any prescribed medications without first discussing the issue with their health care provider. Further research will be needed in this area to provide conclusive evidence.

It is very important to prevent diabetes when possible and to effectively treat it when it is present. The treatment of diabetes should be a team approach, with health care providers and patients working together to ensure patient education and empowerment.

Glaxo replied with a letter to the UK Journal: Lancet.

Two excerpts:

In response to your Editorial (published online May 23)1 regarding the study in the New England Journal of Medicine by Steve Nissen and Kathy Wolski,2 I would like to provide further perspec-tive. Nissen and Wolski estimate a 43% increase in myocardial infarction associated with rosiglitazone. In an associated Editorial, Bruce Psaty and Curt Furberg3 allege that if their estimate is valid there has been a failure of drug use and approval.

We believe that these studies pro-vide clear evidence of the cardiovas-cular safety of rosiglitazone and that the estimates of cardiovascular morbidity from the meta-analyses completed to date are not robust. The drug use and approval system is working. We should stay the course and allow ongoing trials to provide their definitive answers.

Ronald L Krall
ronald.l.krall@gsk.com
Chief Medical Officer, GlaxoSmithKline

My bottom line will be to continue with my Avandia and closely follow the next steps in the USA with both the FDA and Glaxo – you will read about it here: as it happens and unvarnished.

James Montgomery.

Technorati Tags: drugs and diabetes, GlaxoSmithKline, GlaxoSmithKline and heart attack, problems with diabetic drugs, side effects of diabetic drugs, treatment of diabetes

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Tuesday, June 5, 2007

The Satiety Index … a calorie is NOT a calorie

It is with great pride ODB presents the next level of using the GI Index from the SUGIRS team at Sydney University. This article is written by Prof. Jennie Brand-Miller and PHD candidate:  Rebecca Reynolds …. James.

Why do some foods give us the munchies? We just can’t stop at one bite … or two … or three … think chocolate chip cookies, potato crisps, jelly beans … No wonder we call them “more-ish”. Compare this to “old-fashioned” foods (think porridge and beans) that positively stick to the ribs. How hard is it to get more than one bowl of steaming oats down our gullets?

Many experts lay the blame for the current epidemic of obesity right at the food industry’s door. Do they have a secret ingredient that makes us eat more, so we can hold up our arms in resignation and say it’s “dietary trickery”? There may be some merit to this idea. Researchers have conjured up a way to rate foods according to how full they make us feel.

The reasons we start and stop eating are complex. Meal size is partly determined by how quickly you “feel full” during eating, and to what extent. This is called “satiation“. Similarly, the time between meals is determined by how long you feel full for. This is called “satiety“. Psychological factors are of course paramount concerning both, with learned habits, social cues and emotional states having the capacity to override the “basics” underlying eating. However, if one feels full quickly during a meal and for a long time subsequently, psychological factors lessen in significance.

How easy, and enticing, is it to gorge on fruit after a bad day at work? Any takers for eating ten apples in 10 minutes? Conversely, anyone for a warm, moist croissant? Both ten apples and a croissant provide similar amounts of energy, but differ in all other aspects, namely macronutrients, such as fat, protein and carbohydrate, and water, all of which contribute to how full you feel.

“Fullness” is a new buzz word in the world of diet today, and was quantified over a decade ago by Jennie Brand-Miller, Sue Holt and others at Sydney University’s Nutrition Department. Brand-Miller’s team invented a new “scientific” measure of fullness, the “satiety index” (SI). The SI refers to the short-term satiating capacity of a food, i.e. how full one “feels” after ingestion. It was ascertained via a subjective (personal rating) satiety questionnaire, filled out every 15 minutes by healthy human subjects, after a 1000 kilojoule (kJ) portion of a test food was served for breakfast, for a period of two hours.

The higher a subject’s rating of fullness over the two hours, the higher the SI of the food, as compared to a reference food, white bread (which was assigned a SI value of 100). Subjective feelings of satiety were validated by a direct correlation with prospective ad libitum, eat as much as desired, food intake at a buffet lunch after the two-hour test period (i.e. when a subject reported high satiety after breakfast, he or she ate less at lunch). Thirty-eight common foods were tested in this way, each in 12 subjects, with some interesting results.

Croissants had the lowest SI (47) and potatoes the highest (323). In other words, croissants were only half as filling as the same energy load of white bread, while potatoes were over three times more filling. The most satiating foods weighed more and had the highest protein, fibre and water content, less fat content and lower palatability (“tastefulness”). Modern foods, ideally illustrated by the bakery and snacks/confectionery groups, scored low on the SI. Donuts and Mars Bars made subjects feel hungrier and inclined to eat more at lunch. “Wholesome” foods, high in protein and carbohydrate, on the other hand scored highly, with foods like fish and pasta making subjects feel fuller for longer.

The level of distention of the stomach and small intestine is likely to be the main factor eliciting high levels of satiety in the study, reflected by the strong correlation between the weight or water content of the food and SI, i.e. foods with the highest water content, and hence “bulk” were associated with increased feelings of fullness, potatoes being the best example.

This forms the basis of work conducted Dr Barbara Rolls, a US nutritionist, who recommends the use of food volume in weight loss, based on the higher SI of bulky, “watery” food. However, it should be noted that mechanical distention of the gut wall (via mechano-receptors) is only one contributing factor to feelings of fullness. Less obvious characteristics of bulky foods are also important. These include a low glycemic index (GIs), low fat content (and hence low energy density) and high fibre level.

On this note, let us talk about potatoes and GI. Scientists think glucose is a key player in the hunger and satiety tug-of-war via stimulation and inhibiton of “appetite centres” in the brain’s hypothalamus. Potatoes are well known for their high GI and high GI foods are often associated with less fullness (satiation). A blood sugar spike followed by a rapid fall in blood glucose levels can stimulate feelings of hunger. Yet potatoes were the most filling food despite their high GI. Why? Well, one reason may be the fact that the subjects did not rate their hunger beyond two hours. Perhaps potatoes are one of those foods that make us feel only temporarily full. But more important, when we compare high and low GI foods, it is necessary to compare like with like (bread with bread, breakfast cereal with breakfast cereal). With any luck, the potato breeders will come up with a low GI, even more filling potato in the near future.

Previous work has ranked fat as the least, and protein the most, satiating macronutrient, findings supported by the SI, but has often omitted detail on type of carbohydrate and satiety, which was highlighted in Brand-Miller’s study. For example, food with a mix of slowly digestible and indigestible carbohydrate (fibre), such as porridge, scored high on the satiety scale. Oats have high levels of soluble fibre, which forms a gel in the stomach, slowing gastric emptying and hence delivery and absorption of nutrients to and from the gut. Such a viscous mix also “sticks” to the walls of the stomach and upper small intestine, activating mechano- and chemo-receptors and enteroendocrine cells which relay information to the brain via gut-brain signals (such as glucagon-like peptide-1).

These hormones signal the presence of food still in the gut, reminding us that it can take only so much food. In addition, the carbohydrate “inside” a porridge oat is generally harder for the body to process than, for example, white bread. The physical fibrous barrier encasing the oat makes it harder for digestive enzymes to access the interior. White bread in comparison contains starch that is readily available, as all the “tough” outer layers of the original wheat grain have been removed during processing. Indigestible fibre that reaches the lower climes of the small intestine has further effects of stimulating the release of a wider array of gut hormones that signal satiety (for example, peptide YY from the ileum). Similarly, anti-nutrients found in some protein-rich foods, such as baked beans (for example, trypsin inhibitors), may result in some undigested protein reaching these areas and increasing fullness.

Palatability is an important factor to consider, as individual preferences will always influence a subject’s perceived fullness. Measures to control for this were taken by serving 27 of the 38 foods under an opaque plastic hood, to minimise influences of sight and smell, as well as preconceived ideas of the level of fullness a certain food “should” elicit (11 of the foods contained liquid; for example, breakfast cereal with milk, and hence could not be served in small pieces via a hole in the hood).

It makes sense that the more palatable a food, the lower the SI, which is generally the case with high fat foods, as humans have an innate liking of the “rich” mouth feel and taste of fat. This has been hypothesised to maximise the intake of energy-rich fuel (fat is the most energy-dense nutrient) during periods of food abundance in our evolutionary past, in preparation for inevitable times of scarcity. However, today’s times are of abundance, and it is easy to passively over-consume energy via fatty foods, such as cake and french fries. High-fat foods seem to be less capable of proclaiming, “I’m here and I’ve got lots of yummy energy for you” loud or fast enough for our bodies to hear.

In conclusion, the SI ideally illustrates the fact that a calorie is NOT a calorie, i.e. not all kJs are equal. Eat 1000kJ of a fat-laden food and feel less full than after an isocaloric (equal energy) portion of a protein-rich food. In addition, different foods promote varying levels of dietary-induced thermogenesis (DIT, heat production) and fat storage. So, both sides of the energy balance equation have the potential to be manipulated; eat more filling foods to decrease food intake and foods that promote DIT and decrease fat storage to maximise energy output.

The SI is an important concept that has thus far been under-utilised and has huge potential as an anti-obesity tool. So, after reading this article, I’m afraid to say any excess fat “IS your fault”, as now you are equipped with the knowledge of how to identify those foods which try to “go behind your back” and trick your body into letting more of them in. Revert to a more traditional diet, full of foods that score high on the SI, such as porridge, fruit and fish, and stop such “dietary trickery” now.

Professor Jennie Brand-Miller is in the School of Molecular and Microbial Biosciences at the University of Sydney and Rebecca Reynolds is a PhD student, Human Nutrotion, in the School of Molecular and Microbial Biosciences. Many people consider Prof. Brand-Miller to be the ‘Godmather of GI’! Want more like this?

Technorati Tags: between meals, diabetes diet and feeling full, diet for diabetes, feeling full, food and diabetes, fullness, Glycemic Index, living with diabetes, Satiety Index

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Thursday, April 5, 2007

From the Diabetes Desk…

Meet High-tech Harold

Exclusive to the ODB, H-t H is your source
for all that’s new in high-tech battle against
diabetes and its eventual cure.

He will be a regular feature in our new layout
coming soon – all you need to know about
diabetes –especially down under – in one site.Till then you can always read his column right here.

H-t H works for the ODB! 

The Diabetic Lojack

Very much like a prisoner being tracked in a work-release program (except it’s implanted on the inside of your upper arm) — the VeriMed microchip stores your vital health information for times when you are unable to disclose it yourself. It’s about the size of a grain of rice and VeriChip says the procedure is painless.  

Technorati Tags: diabetes, Diabetes Treatments, Glucose reducing drug, living with diabetes, Medication for diabetes, Metformin, Microchip and diabetes, New Diabetes Treatments, RFID Microchip, treating diabetes, Type 2 Diabetes, Verichip Corporation, VeriMed Microchip

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Tuesday, April 3, 2007

From the Diabetic Desk…

Diabetes Alert Day …. And pre-Diabetes!

In the US, today is Diabetes Alert Day.
 

Diabetes Alert Day is held every year on the fourth Tuesday of March to call attention to diabetes and to encourage everyone to find out if they are at risk. While diabetes is often a hereditary condition, it is still possible to develop diabetes even if you have no known history of it in your family. In addition, type 2 diabetes is often preventable through regular medical checkups and a healthy lifestyle.

The focus this year is on prevention and a condition called Pre-Diabetes. You can find out if you are at risk by taking the Type 2 Risk Assessment and then read more below about what you can do to prevent or manage type 2 diabetes.

Prediabetes: Prevention And Treatment

The recommended treatment for prediabetes is similar to the prevention strategies for type 2 diabetes. In many cases, the progression of prediabetes can be halted, and even reversed, by making healthy eating and fitness habits a daily routine.

The Diabetes Prevention Program (DPP), a large-scale study of diabetes prevention strategies in those at high risk for type 2 diabetes (including those with impaired glucose tolerance), found that even moderate lifestyle changes can make a big difference in preventing diabetes and reversing prediabetes in some people. DPP participants who engaged in 30 minutes of physical activity daily and lost 5 to 7% of their body weight cut their risk of getting type 2 diabetes by 58%.

If you have prediabetes, losing excess pounds through proper diet and exercise can improve the body’s ability to use insulin and to process glucose more efficiently. A dietitian or a certified diabetes educator [CDE} can help you develop a food plan that works for you. Our choice is a low-GI diet. Always check with your physician before starting a new fitness program, especially if you have a chronic illness or other health problems.

The DPP also found that the type 2 diabetes drug metformin was beneficial to some individuals with prediabetes/impaired glucose tolerance. Those study subjects that were treated with metformin reduced their risk of getting type 2 diabetes by 31%.

Take the test – as we used to say in parachute school: ‘Knowledge Dispels Fear”!

Technorati Tags: Diabetes Alert Day, diabetes and diet, living with diabetes, Prevention of Diabetes, Testing for Diabetes, Type 2 Risk Assessment, Type 2 Risk Assessment for Diabetes, US Diabetes Alert Day, Weight and Diabetes

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Wednesday, March 28, 2007

From the Diabetes Desk…..

What is Byetta?

There has been a lot of talk in the US over the last 18 months about this new approach for type 2 patients, with the major promotion being headed up by celebrity T2: Delta Burke.

Previous drugs for type 2 diabetes have focussed on doing one of two things – getting the pancreas to produce more insulin or making your insulin work better. Now, a novel approach is enlisting the help of other body organs in the fight against diabetes. 

New classes of drugs are targeting the stomach and the liver, bringing hope for future years of diabetes management and a reduction in side-effects.
Introduced in the USA in June 2005, Exenatide injection Byetta is now taken twice-daily by around 200,000 Americans. It is not an insulin and does not replace insulin, instead it acts to make the body’s insulin work better.

The drug has been reported to have less side-effects than is generally associated with other diabetes drugs. Its most common side-effect is nausea. Some patients using Byetta report losing weight - which can be a bonus in helping to improve management of their diabetes. The drug works by simulating the gut’s reaction to food. It signals the pancreas to make the right amount of insulin after meals to help lower blood glucose closer to normal levels. Once this takes place, it stops the pancreas producing more insulin. The drug also helps stop the liver from producing too much glucose when it isn’t needed, helping to avoid high blood glucose levels (BGLs). Byetta also slows down and moderates the rate at which glucose enters the bloodstream, helping avoid high BGL peaks.

Byetta is an injectable medicine and comes in a 
a pre-filled pen with fixed doses.

How does it work?

In other words Byetta is working four ways:

Exenatide works to help improve glucose control in at least four ways:

Exenatide augments pancreas response to release a higher, more appropriate amount of insulin in response to eating meals; this helps lower the rise in blood sugar rise from eating to more normal, flatter response levels. If blood sugar levels get closer to normal, the pancreas response to produce insulin is reduced. Other drugs (like injectable insulin itself) are effective at lowering blood sugar, but can “overshoot” their target and cause blood sugar to become too low, resulting in the dangerous condition of hypoglycemia.

Exenatide also suppresses pancreatic release of glucagon in response to eating, which helps stop the liver from overproducing sugar when it is unneeded, which prevents hyperglycemia (high blood sugar levels).

Exenatide helps slow down gastric emptying (the rate at which sugar enters the bloodstream) which also helps avoid hyperglycemia.

Exenatide has a subtle yet prolonged effect to reduce appetite, overeating and weight gain. Most people using Exenatide slowly lose weight. Clinical trials have demonstated that the weight reducing effect continues at the same rate through 2.25 years of continued use.

The Future?

Eli Lilly & Co., Amylin Pharmaceuticals and Alkermes, Inc. are currently developing a long-acting-release (LAR) formula of the drug, which would be injected once per week. The initial trials for the medication have shown the LAR formulation to be approximately twice as effective as the original twice-daily injectible form, with a similar safety, lower nausea rates and greater weight loss profile.

And, Australia?

The developers of the drug - Amylin Pharmaceuticals Inc and Eli Lilly - plan to make the drug available in Australia, however a spokesperson from Eli Lilly said it was unknown when Byetta may be available for Australians.

“Eli Lilly has lodged an application with the Therapeutic Goods Administration to register the product in Australia,” she said. “If Byetta is successfully registered, Eli Lilly intends to lodge an application to have it listed on the Pharmaceutical Benefits Scheme (PBS).”

Stay with ODB for the countdown to Byetta in Australia.

Technorati Tags: Byetta, Delta Burke and type 2 diabetes, Diabetes and drugs, drugs and diabetes, living with diabetes, Type 2 Diabetes Byetta

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Tuesday, March 27, 2007

The Stem Cell Debate …………….And a Challenge!

It’s a subject that divides the political landscape, a medical debate that flows through to the whole community. Unless you are diabetic!

Researchers have cured diabetes in mice by injecting bone marrow stem cells into the bloodstream. The stem cells seek out damaged tissue in the pancreas, where they appear to trigger the growth of new cells. If bone marrow stem cells have the same effect in humans with diabetes, they could be used to treat patients straightaway.

“This is a very significant study,” says Joel Habener of Harvard Medical School in Boston, who studies stem cells in the pancreas. “It suggests that there is something in the bone marrow that can stimulate the pancreatic stem cells to regenerate.”

It can take decades to bring a new drug to the marketplace. But bone marrow transplants have been used for years to treat a host of blood disorders, including leukaemia and sickle cell disease. They have been proven safe and would require no government approval for use as a possible diabetes treatment in humans.

“There’s nothing to prevent people from trying this in humans,” says Habener. “People with diabetes have been waiting for a cure for years and years. Why not go ahead and try?”

The Current Status

That was a couple of years ago – but its back in the news again. The Prime Minister allowed a conscience vote in the parliament over whether or not that ban should be lifted. The ban was lifted last December. The Victorian Parliament votes this week.

Meanwhile, research in the US has slowed right down …   Small companies working to develop human embryonic stem cell therapies face innumerable challenges when looking for funding, according to several industry executives at the second annual Stem Cell Meeting in San Francisco on Monday.

Unlike the traditional biotechnology sector, in which government agencies provide primary funding before early-stage venture capitalists move in to invest and assume risk, the lack of support from U.S. President George W. Bush’s administration has led stem cell research to be viewed as too risky an investment, the executives said.

Last August on Channel Nine’s Sunday, Kristine Lumb talked to leading experts representing both sides of the debate.

Here is what Elizabeth Finkel said….

ELIZABETH FINKEL, BIOCHEMIST, SCIENCE WRITER, CONTRIBUTING EDITOR COSMOS MAGAZINE:

“We’re not talking about copying people; we’re talking about copying their cells. if you for instance had type one diabetes what we would hope to be able to do is take one of your skin cells, and if we imaged that everyone of your cells is running a program, what is doing the programming, is like a little hard disk inside the cell called the nucleus.

We can reboot that little hard disk back to it’s original operating program where it could run all programs, so we would take that skin nucleus, and we would inject it into one of your own eggs whose own nucleus had been removed and now that the contents of your egg would reboot your skin nucleus and it would start developing as if it were a little embryo clone of you, a very primitive little embryo clone of you. It would then be used to derive embryonic stem cells and those stem cells would be coaxed to become pancreatic cells, insulin producing pancreatic cells and you would be able to have a graft of your own cells, no anti rejection drugs required.”

The International Society for Stem Cell Research

Co-sponsored by the Australian Stem Cell Centre (ASCC), this year’s ISSCR Annual Meeting will be held in the tropical city of Cairns in June.

The Biotechnology Centre of Excellence programme, the Australian Stem Cell Centre, will receive an additional $30.4 million from the Department of Industry, Tourism and Resources, and $27.5 million from the Australian Research Council (ARC). This brings the total funding from the Australian Government to $57.9 million over five years from 2006–07 to 2010–11.

The Challenge

I must be missing something – everything seems to be in place. We do have funds in Australia and the expertise.

Joel Habener of Harvard Medical School put it best….

“There’s nothing to prevent people from trying this in humans. People with diabetes have been waiting for a cure for years and years. Why not go ahead and try?”

Why not?

Technorati Tags: cures for diabetes, diabetes, diabetes and stem cell research, living with diabetes, possible cures for diabetes, stem cell and diabetes, the stem cell debate, type 1 diabetes

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Wednesday, March 14, 2007

Type 2 – a Personal Approach to Diabetes Control

I am now 65 – was diagnosed over a dozen years ago and have maintained a pretty constant HbA1c below 7.0.  This contrasts pretty much with my very busy lifestyle and home life; starting new businesses and raising an 8 year old daughter. The majority of my business associates don’t know that I am a diabetic.

My regimen is based on simple and easy to follow rules in my diet, my exercise and my medication.   This works for me; it doesn’t necessarily work for you … I have been lucky to work with some of the best GP’s and endocrinologists below the equator.  So the first step in my program is – talk to your doctor, see him or her every three months. This is not one to do on your own!

DIET

If this is not your first visit to the ODB, you will know we are great supporters of the Glycemic Index.
Not all carbohydrates are evil is the motto of the low GI diet. As a measurement of how quickly a particular carbohydrate is used by the body, the Glycemic Index is already found on nutritional labels in Europe and Australia, but has yet to be endorsed any American organization.

Manufacturers have prepared low-GI foods and I make great use of their products.
Bread is a staple in my house and I make sure it’s a low-GI product.
That’s what’s so different about the GI, it’s not low carbohydrate, it’s more selective carbohydrate.

Foods with low GI are metabolized slower, meaning they sit in your digestive track longer and are gradually absorbed by the body. This leads to a more gradual blood glucose increase, keeping your hunger satiated longer. You feel ‘fuller’! More on feeling full later in the week.

How do I fit this into my lifestyle – in my wallet is a go/no-go list … last week I gave you my list of go foods …. now for my list of no-go

No-Go No. 1  Spuds   I have learned to swap white potatoes with sweet potatoes and yams; not to eat them when I am out.  If you must occasionally scratch your potato itch, cook them the day before in a salad and put them in the fridge overnight … it slows down the rate of digestion of the starch.

No-Go No. 2  Breakfast Cereals  I obviously don’t chow down on Coco Pops; but you may be surprised at the others in the hi-GI list; they include Cornflakes, Bran Flakes, Total, Rice Bubbles, Sultana Bran, Cheerio’s, Weet-Bix is borderline.

No-Go No. 3  Staples  Poor old potatoes, they get a pasting again [no fries and no mash] along with short grain white rice and tapioca.

No-Go No. 4  Snacks   Not what you think: the drop-em list includes pretzels, water crackers, rice cakes, the ubiquitous scone and as you would expect: maple syrup and donuts.

No-Go No.5   Fruits    The two traps for the unwary are watermelon and dates.

No-Go No. 6  Vegetables  There are two here too: parsnips and pumpkin.

No-Go No. 7  Bread   The usual culprits: white [unless modified and proudly wearing its low-GI label], bagels and French baguettes.

And, that’s not that hard to remember! Here is a full list online … David Mendosa is a diabetic treasure!

EXERCISE

This is a no-brainer!

You can prove the effect of exercise to yourself simply by checking your BGL before and after a half hour brisk walk. I sometimes even risk a hypo.

New research shows that moderate exercise, such as walking, cycling, or jogging, can significantly reduce the risk of death for people with Type 2 diabetes. This study followed over 3,300 people and correlated their level of physical exercise with mortality to find that moderate exercise reduced the chance of cardiovascular death by 9%, and more vigorous exercise reduced the total chance of death by 33%.

To people with diabetes, this probably isn’t new news. We have long been advised to pursue physical exercise, especially cardiovascular exercise, in order to improve their overall health and reduce their chance of death. This study simply adds support to the notion that physical exercise is the number one way to enhance your health and avoid the downward health spiral associated with diabetes.

Now, don’t rush off and join a gym. Healthy exercise can be as little as three thirty minute workouts a week with time beforehand to warm up and a cool down time afterwards.

I do some stretching exercises and speed walking for twenty minutes.

A couple of do’s and don’t’s: drink plenty of water and take it easy –this is meant to be moderate.   Don’t hold your breath when you feel the strain, breathe out; don’t stand still after your twenty odd minutes of speed walking, walk around slowly as part of your cool down.

You want to get into this deeply –try Professor Bob Montgomery’s book: Your Good Health –it also contains a good section on giving up smoking as well. My last puff was over 25 years ago! Bob was a pioneer in so many areas of good health.

Now that I am over 60, I make that five mornings a week rather than the minimum three whenever I can. It makes me feel good!

MEDICATION

Keep in mind that drugs are not magic. If you are taking a drug for diabetes control, it is still essential that you follow a good diet and get regular exercise. These two elements of diabetes control are the pillar on which all other diabetes treatment rests.

I have a cocktail of three prescription medicines:
Metformin:  It works by helping the insulin that your body is still making work better. It also has a side effect which is very beneficial for most people with Type 2 diabetes—it makes you lose a little bit of weight by decreasing appetite. Another good side effect for some people is that it tends to lower triglycerides (certain fats in the blood), which is great if you tend to have high triglycerides.
Glibencalmide: It works by making your body produce more insulin. As you probably know, when you have type 2 diabetes, your body is able to make some insulin, but not quite enough to overcome the insulin resistance that your body has. When you take these drugs, your body is able to make a little more insulin.
Thiazolidinediones: I use a brand name called Avandia. These drugs work by helping the insulin that your body is already making work better, but they work on different parts of your body than metformin does.

Each performs a slightly different function.

I cannot stress too much that this works for me and you need to discuss dosages and oral mixes with your own doctor.

As I said, I was diagnosed as a T2 nearly fifteen years ago now, I have a heavy family diabetic history, so I guess it was inevitable …but, touch wood, the above regime has kept my HbA1c below 7.0 for the last five years. It’s not meant for you, it is meant to make you think!

Note: the cartoons are from a cool diabetic information site and the clever wit of Mike Adams and with help from Dan Berger.

Technorati Tags: control of diabetes, controlling diabetes, diabetes and diet, diabetes and exercise, diabetes control, diet and diabetes, GI, information on diabetes, living with diabetes, medication and diabetes, Type 2 Diabetes

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Monday, March 12, 2007