Friday, September 22, 2006

Diabetes Control Requires Options Based on Data

Last weekend the European Association for the Study of Diabetes convened in Copenhagen for their 42nd annual meeting. As reported in Zee News, Dr. Targ Elgzyri from Lund University, Malmo, Sweden presented data that found "people who develop type 2 diabetes when they're younger than 50 years of age are more likely to experience a worsening of their disease than those diagnosed at an older age."

He said the study was conducted because "we found, as previously shown, a progressive rise in HbA1c over time in newly diagnosed patients with type 2 diabetes despite different modes of therapy."

To gain an understanding of what drives progressive decline, the researchers investigated non-genetic factors that influence a rise in HbA1c levels. The HbA1c level is blood marker that gives a snapshot of average blood sugar levels over several months. The higher the value, the higher the average blood sugars were in the past few months before testing. It is considered a more precise measure than daily finger testing that those with diabetes do each day as it measures the average blood sugar level throughout the day, which helps determine glycemic control over time.

In this study, the researchers followed more than 1,200 patients with type II diabetes for seven years after their diagnosis. HbA1c improved at 1 year following diagnosis, declining from 7.6 to 6.3 percent. During the subsequent 6 years, however, HbA1c increased from 6.3 to 7.0 percent, as expected.

The patients required insulin therapy after an average of 2.5 years, Elgzyri and colleagues report in a meeting abstract. After 7 years, 47 percent of study subjects were on insulin therapy.

"Among non-genetic factors studied, age at diagnosis showed a significant influence on HbA1c change over time," Elgzyri said.

Specifically, patients younger than 50 years at type 2 diabetes diagnosis experienced a steeper increase in HbA1c than did those 50 years of age or older at diagnosis.

The researchers concluded this was due to a progressive decline in the ability of the pancreas cells to produce insulin in those diagnosed before age 50.

The results of this study confirm findings of other studies, namely the rebound from improvement to decline often seen in those trying to control blood sugars with the recommended diet, exercise and incremental increase in drugs. Back in June I wrote about a study published in the New England Journal of Medicine that found at the six-month and one-year follow-ups there were dramatic changes for those who modified their lifestyle - impressive improvements in fasting blood glucose (FBG).

At baseline those in the lifestyle intervention group had an average FBG of 106.3mg/dL which declined over the first year to just a hair above 100mg/dL. After the first year, their fasting blood glucose levels rebounded however, so for the first year the diet and exercise did have a positive effect - but that was lost over time as fasting blood glucose did a rebound and ended higher at the conclusion of the study than at baseline. So, after three years of the lifestyle intervention, while they weren't diabetic, those in the intervention group experienced an overall negative effect on fasting blood glucose - it worsened over time.

The same disturbing trend is seen with regard to the HbA1c levels. Initially HbA1c improved only to rebound over time with the follow-up levels higher than baseline - HbA1C worsened over time.

This "negative outcome" has led many within the diabetes community to conclude that progression is just part of the disease, there is little that can stop it, and the best course is to initiate pharmaceutical interventions earlier.

The American Diabetes Association [ADA] recently updated their treatment algorithm to include metformin at diagnosis where previously those diagnosed were encouraged to adopt diet and lifestyle modifications as their first line defense to manage the disease.

Other organizations, including the American Association of Clinical Endocrinologists [AACE], are taking a more aggressive approach and recommending intensive intervention to reduce and manage HbA1c when an individual is identified with pre-diabetes (a fasting blood glucose above 100mg/dL and/or impaired glucose tolerance identified with a GTT resulting in blood glucose at or above 140mg/dL after two hours).

The AACE position is that upon diagnosis of pre-diabetes, an HbA1c test is in order and glycemic control, to effectively and safely lower it, specifically below 6.5%, is critical. In their consensus statement, they point to studies that repeatedly find the ADA target of 7% too high to prevent complications and therefore establish a lower target to reduce the risk of complications.

Their "Roadmap to Achieve Glycemic Goals" is comprehensive and starts intervention as early as an HbA1c of 6%.

The reason is found in the translation of HbA1c results as a measure of daily glycemic control:

When we see this type of meaning detailed simply for us, it is easier to understand why glycemic control is so important. It is also clear the ADA target is set too high! An HbA1c of 7% means the person at that target maintains an average blood glucose level of 170mg/dL. It is that ongoing state of hyperglycemia doing damage each day that is leading to complications in the long-term.

The biggest challenge to reducing HbA1c is determining which course of treatment will effectively enable a person with higher than desired blood glucose levels to reduce them and manage them for the long-term in the normal range or as close to normal as possible.

The standard today is to recommend diet, exercise, and more recently medication at diagnosis. However, a growing number of experts within the diabetes community are growing weary from the lack of results when the recommended diet fails and often makes things worse. These failings are not for lack of trying - the problem is the recommended diet exacerbates an already challenged metabolism because it includes too many carbohydrates.

Such a simple reason does not deter the staunch believers of decades old dietary dogma however. Recently this was clear in a dLife segment that featured Dr. Richard K. Bernstein, MD and Hope Warshaw, MMSc, RD, CDE - who are at opposite ends of the dietary spectrum for glycemic control with diet. The transcript of the show may be found here.

As Dr. Bernstein, who recommends a carbohydrate restricted diet in his medical practice, wrapped up his time, he ended by leaving viewers with one simple sentence, someone diagnosed with diabetes is "entitled to the same blood sugars as a non-diabetic and its up to you to get it."

Ms. Warshaw didn't challenge this, but instead opened her time with "I want to make three quick points. Number one, the research shows that low-carb diets don't work. People can't stay on them long-term and they're simply not a healthy way of eating. Number two, people with diabetes deserve to eat healthy and enjoy food. Number three is the carb issue today is not a quantity issue; it is a quality of carbohydrate issue. What we're eating too much of is added sugars, regular soda, fruit drink, and sweets. So what Americans need to do, I believe, is that they need to move those calories into healthier carbs, okay?"

As she continued, she said "[t]he vast majority of people with diabetes need medication. I mean what we know today about diabetes management is that it is good blood glucose control, good lipid control, and good blood pressure control that keeps people healthy long-term. And I feel people need a realistic way of eating."

Evidence versus sophistry; with just enough opinion thrown in to ensure glycemic control remains elusive to those who try their best with the recommended diet.

The available data reminds us that truly isn't a question of "if" but "when" the diet will fail, there is progressive damage as HbA1c rises; this is because the recommended diet makes it impossible to achieve normal blood sugars over the long-term.

Re-read the second part of her statements - she acknowledges that blood glucose, lipid and blood pressure control keeps people healthy long-term but then opines that dietary advice should be "realistic," and from her opening statement, such a diet should be "enjoyable" to the person attempting to use diet as a means of controlling their blood glucose. Forget glycemic control is the priority, it's critically important to eat and enjoy your food even if it is going to kill you slowly with progressive damage.

This type of thinking sets the course for progressive damage because the dietary recommendation includes too much carbohydrate to make glycemic control even remotely possible, even with a high target HbA1c of 7% or less!

Ms. Warshaw's contention that without abundant carbohydrates a person is at risk of consuming a diet that is unhealthy and what matters is the quality of the carbohydrate belies the fact that all carbohydrates (except fiber) are metabolized to glucose - some are just not converted to glucose as quickly as others. While she contends quantity is not the issue, but quality is, the hard fact remains the absolute grams of digestible carbohydrate consumed each day is the number one influence on blood glucose levels.

This isn't opinion, but established metabolic fact.

But those who cling to the orthodoxy that dietary fats are detrimental to health, cannot step back from their position without admitting error; cannot acknowledge that the past is where we can understand how we got into the situation we are in today; and cannot find it within themselves to say "we were wrong, we're sorry," but let's move forward and do the right thing so you can reduce the risk of complications now and tomorrow.

The solution will not be found in simply modifying the type (quality) of carbohydrate consumed. While that will provide a small measure of benefit, at the end of the day, such a modification will not provide enough control unless the total digestible carbohydrate - selected for quality - is reduced significantly in the diet of those with pre-diabetes or type II diabetes.

This month Endocrine Today highlighted the remarks of Ann Albright, PhD, RD (president-elect of the ADA) who said, “When you’re talking about diabetes, there is no ‘one-size-fits-all’ diet. For people with diabetes and those at risk for type 2 diabetes, medical nutrition therapy should be tailored to a person’s specific health issues and personal preferences to help maintain optimum health by controlling blood glucose levels, blood pressure, cholesterol and other risk factors. We hope these recommendations will help people make better choices about what they eat and how they live to maximize their chances of staying healthy.”

It's clear from the MNT document released by the ADA that the personal preference better not be a carbohydrate restricted diet. It's clear from the statements from Ms. Warshaw, with a number of books published and endorsed by the ADA, that such a dietary approach could not be possible nor enjoyable for someone with pre-diabetes or type II diabetes.

I find this only hypocritical, but downright patronizing and limiting patient autonomy!

The "powers that be" are doing all they can to convince the public that a carbohydrate restricted diet is untenable, unhealthy and unrealistic for controlling blood glucose. Just ignore the data and follow their prescription for the long-term; ignore that the data shows their recommendations directly lead to progressive damage, poor glycemic control and progressive increases in medication requirements.

What is so frustrating about this whole situation is that while there will most definitely be a population of those diagnosed with pre-diabetes and diabetes who simply know themselves well enough to know they will not be able to restrict carbohydrate, such stubborn refusal to include carbohydrate restriction as a scientifically supported option is leaving those who would jump at the chance to give it a go from invesitgating it because it's next to impossible to find a physician, healthcare provider or dietitian knowledgable enough in the details about how to follow and monitor a carbohydrate restricted diet properly.

How much longer is the medical community going to stand by and accept less than acceptable results when they have patients fully complying with the recommendations who simply continue to decline because the recommended diet is flawed and is directly contributing to the progressive decline in health?

How much longer will those at risk for or diagnosed with diabetes accept such a guaranteed-to-fail approach from the ADA, the organization they depend on for timely and cutting-edge evidence-based approaches to help them?

I've said it many times before, I do not expect a ringing endorsement from the ADA that a carbohydrate restricted diet is the best dietary approach (even though the evidence clearly points to it as). No, what I expect, and what those at risk for or diangosed with diabetes should expect, is an acknowledgement of the data and a clear, comprehensive guideline provided to those who choose to adopt a carbohydrate restricted diet as their first line defense.

That is true patient empowerment - providing them the options, requirements of each and then allowing them to decide which they will be able to comply with best in the long-term.

It is not up to the ADA to decide what a patient may or may not want to eat - it is the responsibility of the ADA to communicate the findings from studies and communicate how to implement those approaches where statistically significant benefits are found in clear manner so healthcare providers and patients can use the data in their daily management of their disease.

As it stands, the ADA is failing those at risk for or diagnosed with diabetes each day that passes without an honest review of the evidence of carbohydrate restricted diets. It's time for those at risk for or diagnosed with diabetes to stand up and be heard - tell the ADA to get back on track and follow their mission, clearly stated on their website, "to prevent and cure diabetes and to improve the lives of all people affected by diabetes."

A carbohydrate restricted diet has been shown in a number of studies to improve the lives of those with diabetes - and anyone at risk for or diagnosed with diabetes deserves nothing less than full disclosure of the option as a way to manage their blood sugars.

Anything less than a comprehensive guideline is unacceptable and directly causing progressive damage in those denied this critical information to make a choice in their medical care!

That the experts at the ADA find the data hard to digest is of little consequence when we're talking about millions of lives here - they don't have to like the data, findings or results - all that matters is the data is what it is and patients deserve to know what benefit may be possible if they choose a carbohydrate restricted diet.


  1. "Number one, the research shows that low-carb diets don't work. People can't stay on them long-term and they're simply not a healthy way of eating."

    Number 1, this is 3 points.

    “Low-carb diets don't work.”

    There are a number of studies that indicate they do work, usually more effectively than low fat diets.

    “People can't stay on them in the long term.”

    There is a grain of truth to the assertion. This is just as true of low fat diets or any diet for that matter. However, a significant percentage of people do stay on them (low carb diets) in the long term.

    "They're simply not a healthy way of eating."

    Numerous studies have attempted to prove that, most recently the WHI Women's Health Initiative which attempted to prove a low fat diet promoted better health. The results of these studies are, at best, inconclusive in spite of the hundreds of millions of dollars spent on them.

  2. Anonymous2:06 PM

    Hey Regina, why not start a newer, better national diabetes organization? Waste of energy to hammer at the current one. It's not govt anyway so why not ignore them and let them fizzle.

    There is precedent for such a move.

    Ref the story in New York history. The opera society wouldn't let "new rich" in. So the "new rich" made their own, the Metropolitan Opera. Today the Met is going strong and no one remembers the earlier one.

  3. If only I had the money!

  4. As for low carb diets being hard to stay on, I don't think so! I have been eating low carb now for 6 years. The longest I'd ever stayed on a low fat diet was 3 months. But once again it is the old tell a lie often enough & people will eventually acept it as the truth !! Even when the lie flies in the face of empirical evidence ! Spin doctoring makes the world go round & we should never let the truth get in the way of a good ad campaign now should we??

  5. I was diagnosed with type 2 diabetes back in January and have since adopted a low carb lifestyle. When I saw the dLife segment with Hope Warshaw & Dr. Bernstein, I wanted to reach through the TV and shake Hope.

    Low carb doesn’t work? After 8 months, my glucose control is near normal non-diabetic levels. I’ve been able to get off some of my medication. I am 80 lbs lighter than I was a year ago. My cholesterol came down to the point I am no longer hassled about statins. I no longer experience the insatiable cravings that sabotaged my weight loss efforts in the past.

    People can’t stick to low carb and it isn’t enjoyable? I have no problem sticking to it. It’s much easier to stick to than the low fat approach I followed for 20+ years. I find it much more enjoyable than the low-fat & fat free stuff I used to eat. It’s much tastier, even without sugar. Due to my diabetes, I may have to continue my current level of carb restrictions for the rest of my life, but I can do it. I couldn’t say the same for the low fat approach.

    Not healthy? I eat a variety of non-starchy vegetables along with a variety of protein – meat, poultry, fish, cheese, eggs. I also include extra virgin olive oil. I avoid sugar and other refined carbohydrates. Also, refer to my improvements in glucose and lipids above.

    Quality vs. quantity of carbs? I ate plenty of “healthy” carbs before I became diabetic, but ate way too many. Quantity is important too.

    As for the ADA target HbA1C of 7, Dr. Bernstein points out that most normal non-diabetics keep their blood sugar around 83 – 85. The ADA target represents an average blood sugar of 170 – twice that of normal non-diabetics. Organ damage can occur at levels about 140 and damage to beta cells in the pancreas can occur at levels higher than 110. I saw the result of a study that even an HbA1C as low as 5.6 still carries an increased risk of heart disease. I’m beginning to think that the ADA is doing more to benefit the drug companies than diabetics.

    I have been fighting with weight most of my life. For the last 15 years I’d been gaining and eventually got up to 350 lbs. I went to Weight Watchers and lost over 50 lbs, but that was short lived. While continuing to attend Weight Watchers, I went up and down and, last summer ended up back where I started plus a few pounds. At that point I just gave up trying to lose weight. With the insatiable cravings, I thought it would never happen and I should just accept myself as is.

    Then the wake up call came in January. At diabetes education, I was told to eat low fat and follow the food pyramid. With the help of medications and laying off sugar, my blood sugar came down to the low 100s, but the insatiable cravings were still there. My wife had been suggesting that I try low carb, but I had been brainwashed by the low fat dogma. I finally came to my senses – they were telling me to keep doing what I was doing before – the very thing that got me in the mess. I switched to a low carb lifestyle via the Schwartzbein Principle. The approach recommended by Hope Warshaw and the ADA failed to help me attain a healthy weight and didn’t prevent me from getting diabetes.

    It’s scary to contemplate the study you mentioned – that glucose control gets better during the first year and then gets worse. I am still in my first year and under 50 years of age. I hope to beat the statistics with a low carb lifestyle. Time will tell.