Tag Archive for: HbA1c

It’s Still All About the Calories

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The keto vs. Mediterranean diet study was interesting for a variety of reasons. The researchers deserve a lot of credit for even attempting to try a study of this magnitude; 40 subjects may not seem like a lot, but to provide food via delivery together with instructions on preparation is very expensive and labor intensive. It should be noted that a portion of the study took place during the lockdown phase of COVID-19; that delayed some testing, but to their credit, the subjects affected continued the particular diet they were on for the two weeks until testing could be scheduled. Here are my thoughts on the results.

Blood Lipids

  • Subjects on the keto diet showed a greater decrease in triglycerides (TG) than those on the Mediterranean diet.
  • On the other hand, those on the Mediterranean showed a greater decrease in LDL-cholesterol than did the keto diet subjects.

While the researchers discussed it at length, I don’t think it was relevant. All subjects began with average fasting TG in the normal range. While both diets decreased TG, that the keto diet reduced it slightly more isn’t earth shattering when you start at a normal reading.

The same holds true for the LDL-cholesterol. Yes, the Mediterranean diet reduced it while the keto diet increased it, but the net was 6 mg/dl over the initial readings. What could have been concluded was that neither diet reduced LDL-cholesterol by an amount that was clinically meaningful.

The Microbiome

There were no tests of the changes in the microbiome under each diet reported—at least not yet. Subjects had a definite decline in fiber intake, especially when they provided their own food in the keto diet. The Mediterranean diet saw an increase in fiber intake when subjects provided their own food.

Why mention this at all? The microbiome controls the initial processing of nutrients. In addition, the immune function begins in the gut. While the keto diet may have provided some benefit related to HbA1c, at what cost? We simply don’t know. What we do know based on other research is that the lack of fiber changes the probiotic content of the microbiome.

The Bottom Line

The data showed that the subjects averaged 200 to 300 fewer calories per day regardless of diet and maintained the reduction over both diets. They ate better, they ate less, and they lost weight.

I think this study was important because it leaves us with better questions to ask in the future, such as: how would health measures be affected if subjects reduced calories another way? It also proves what I’ve been saying for years. The average weight loss after the study was 13 to 17 pounds, and that was maintained during the follow-up period. This was not a weight loss study, yet regardless of the initial diet, the subjects lost weight. I’ve said it before and I’ll say it again: regardless of the type of diet, it’s still all about the calories.

What are you prepared to do today?

        Dr. Chet

Reference: AJCN doi.org/10.1093/ajcn/nqac154

Face-Off: Mediterranean vs. Keto

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Last week ended with the publication of an interesting study on two popular diets, Mediterranean and ketogenic, and their potential benefits for people with elevated HbA1c levels; HbA1c is a blood test that measures your average blood sugar levels over the past three months. I use the word “diet” as a description of the type of foods eaten, not as a weight loss program.

The researchers constructed what they termed the Well-Formulated Ketogenic Diet plan to compare with a Mediterranean diet. Both approaches reduced sugar, refined carbohydrates, and starchy vegetables; the Mediterranean diet added unprocessed whole grains, beans, and fruit. The subjects had either prediabetes or type 2 diabetes. The primary goal of the 36-week program was to monitor changes in HbA1c along with a variety of secondary measures including blood lipids.

The 40 subjects were randomly assigned to using the keto diet for 12 weeks and then switching to the Mediterranean diet for 12 weeks or vice versa. Food was delivered to all subjects for the first four weeks of both phases, which I think is brilliant—one of the hardest parts of learning a new way of eating is discovering how the foods can be combined and prepared, along with getting used to the different tastes. After those four weeks, they provided their own food that fit within the particular diet they were on at the time. The final 12 weeks were left up to the subjects.

The results demonstrated both dietary approaches reduced HbA1c about the same amount, and the decrease was maintained regardless of which diet they began with. However, there were some differences as well. I’ll give you those on Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: AJCN doi.org/10.1093/ajcn/nqac154

Researching GOLO’s Claims

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Before I get into the rest of the research on the claims made by GOLO, I want to be clear that I have nothing against any products or programs in the market. I’m not assessing the entire program for any company. But having worked for a couple of decades with companies that follow the FDA and FTC Guidelines for dietary supplements very closely, it’s more than frustrating when companies play loose with the research. If they make a structure-function claim, they should be able to substantiate those claims according to the guidelines.

Published Studies

The GOLO website refers to two studies that were published in journals. In the first study, a researcher assessed the effectiveness of the GOLO program on measures of weight and glycemic control. The study lasted 13 weeks; 16 out of 26 subjects completed the trial. There were significant reductions in body weight and insulin levels.

In a second study, the same researcher compared the subjects who used the GOLO weight loss program. The control group was given a placebo and the experimental group was given the program’s dietary supplement. The treatment group lost more body weight than the controls; there were also positive changes in serum insulin and a score of insulin resistance.

The implication is that in all studies, published or not, the dietary supplement made the difference in the results. There’s no way to tell. While every study talked about caloric intake, they did not report comparative data, either within subjects when there was no control group, or between groups when there was. This is simply poor research methodology and statistical analysis.

Does the Research Prove the Claim?

As I said on Thursday, while the company makes many claims on the website, I stuck to the one that said the product was “clinically proven to reduce insulin resistance.” They did not prove that the dietary supplement helped reduce insulin levels, blood glucose levels, or HOMA-IR, a measure of insulin resistance. There were just too many confounding variables they did not examine. I already made mention of the caloric intake. The program evolved over time from one where they planned a 500-calorie deficient diet for the subjects to one where they were advised on how to construct a diet from certain food selections. That’s why caloric intake is so important; we need to know that to find out how well the subjects met the dietary guidelines. The best they could claim is that the supplement may have assisted some subjects to lose weight.

In each study, the changes in HbA1c were relatively meaningless in the real world; reducing HbA1c by 0.18% and 0.61% is within the error of the method. As for the use of HOMA-IR, the researcher who developed the algorithm has said that it was not suitable for these types of clinical trials, just for large epidemiologic studies. Finally, the reduction in blood sugar in every trial where it was measured could be explained by exercise, which they also did not account for in the analysis; many people don’t realize exercise can modify insulin resistance by the third workout.

The Bottom Line

There were many more issues with the selection of data used in the multiple analyses and in the choice of statistics themselves. Most importantly, the significant loss of subjects—all four lost up to 40% of all subjects—was acknowledged by the authors, but they didn’t explain its impact. I could go on with errors, but it’s unnecessary. For the claims made, the level of substantiation is simply not sufficient to exhibit the dietary supplement’s benefit for insulin resistance. The weight loss program may be beneficial, but it can’t be verified by any of the studies they completed or by the materials provided on their website.

Eat less. Eat better. Move more. Do those long enough and you will be able to lose weight, get fit, and improve your metabolism as well.

What are you prepared to do today?

        Dr. Chet

References:
1. Diabetes Updates, 2019 doi: 10.15761/DU.1000125.
2. Trends Diabetes Metab, 2019 doi: 10.15761/TDM.1000109.

Does Fiber Improve Your Microbiome?

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Now let’s look at the results of increasing dietary fiber for people with diabetes. Researchers recruited over 50 type 2 diabetics (T2D) for a 12-week study. The control group was given standard recommendations for a healthy diabetic diet. All current medications were maintained and both groups received acarbose, a starch blocker. The experimental group was put on a diet of prepared high-fiber foods and a diet higher in vegetables and fruits. Stool samples were collected periodically to assess the impact of the diet on the microbiome.

While the variables were straightforward, the analytic techniques were extraordinarily complex. It’s easy to say you want to examine the microbiome, but that’s not simple to do with thousands of types of microbes to analyze. Several types of bacteria from different species responded to the increase in fiber: bacteria that produced short-chain fatty acids (SCFA). The SCFAs are important because they feed the cells in the gut that do all the work during digestion and absorption.

HbA1c levels decreased faster and in a higher percentage of subjects in the experimental group than the control group. The fiber group also lost more weight and their blood lipids improved more than controls.

This was a small study, limited by the complexity of analyzing the microbiome, but the improvement in T2D simply due to an increase in fiber from foods is important. One more thing: this was a Chinese study, so typical high fiber foods from China were used. Is that important? We’ll find out Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: Science. 2018. 359:1151–1156.

Health Headline: Ketogenic Diet and Type 1 Diabetes

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Researchers wanted to examine the blood sugar control of type 1 diabetics who use a very low carbohydrate, high-protein, moderate fat ketogenic diet. The diet was developed by Dr. Richard Bernstein, himself a type 1 diabetic. They used a unique study design: they requested volunteers from a Facebook group of children and adults who adhere to the Bernstein Diet. Over 300 volunteers completed an online survey about their diagnosis and diet. The diagnosis of type 1 diabetes was confirmed from medical records from a follow-up survey of medical staff.

This was a rigid ketogenic diet with no more than 30 grams of carbohydrate allowed per day. The average intake was 36 grams carbohydrate per day. The better the control of carbohydrate intake, the better the HbA1c score, with a mean of 5.7%. Remember, these were type 1 diabetics; there are many type 2 diabetics who don’t control their HbA1c that well. I think this study illustrated the potential of nutrition in affecting a disease system. One interesting aside was the healthcare professionals treating the patients seemed indifferent to the dietary approach regardless of the results.

Headline worthy? Yes, in context. Close to half the subjects did not provide access to medical personnel so the researchers relied on the initial subject surveys for information. They also had no access to any dietary records to confirm the diet. Still this was a unique way to use social media to gather information. The study has to be confirmed using traditional research design to assess the variables. But this approach examined people who live this diet on their own or with their children. That can provide insights that might be missed if the study were conceived by a group of research professionals discussing the question around a table.

What are you prepared to do today?

Dr. Chet

 

Reference: Pediatrics. 2018. doi: 10.1542/peds.2017-3349.

 

Guidelines for Type 2 Diabetes: EBM in Practice

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The American College of Physicians (ACP) has established guideline statements for the management of HbA1c in non-pregnant adults using medication. They considered the research behind guidelines set by four other major physician organizations for treating type 2 diabetes. After reviewing that data, they have proposed four guidelines for use when treating patients. These are non binding guidelines; the choice is always left to the physician and the patient. But I think they get back to what evidence-based medicine should have always been about: use the best science and research and work with the patient to see what they want to do. Let’s take a look.

ACP Guideline Statements

These are the statements:

Guidance Statement 1
Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of benefits and harms of pharmacotherapy, patients’ preferences, patients’ general health and life expectancy, treatment burden, and costs of care.

Guidance Statement 2
Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes.

Guidance Statement 3
Clinicians should consider de-intensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%.

Guidance Statement 4
Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population.

EBM and Guideline Statements

I think the Guideline Statements reflect what EBM was always supposed to be about: consider the patient and what they want. I have spoken to many adults with type 2 diabetes who become frustrated with their inability to reach the HbA1c goals their physician has set. If they can’t reach it, more medication seems to be the only solution, and that’s not what they want.

I think these guidelines bring the patient or their caregiver into the equation. What price does the patient have to pay with their body? How much will it affect their life positively or negatively? Are there real improvements in quality of life if the HbA1c is 6.5% versus 7.0%? What is the cost of emotional stress?

The new guideline statements are a great addition to a physician’s repertoire: treat the patient as an individual. The patient comes before statistics and hazard ratios.

The Bottom Line

While not all organizations are going to adopt these guidelines, they’re important. There has been significant pushback from other organizations, all suggesting that there are new medications that may prevent some of the negative effects of prior treatment. “New medications”—they’ve learned nothing.

The one opportunity I see is that there’s hope for all of us who want to work at getting control of our lifestyle and reduce the dependence on medications as recommended by statement three. You say you don’t want to take medication? Excellent! Here is your chance to prove it.

Eat less. Eat better. Move more.

What are you prepared to do today?

Dr. Chet

 

Reference: Ann Intern Med. doi:10.7326/M17-0939.

 

What Is Evidence-Based Medicine?

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The term evidence-based medicine (EBM) dominates the scientific literature related to the treatment of disease. In short, the use of EBM is intended to treat patients based on the best available science and research; only the largest, best designed, and strongest studies are used when setting up the standards for treatment. That seems to make sense. That applies to the use of medications for the treatment of type 2 diabetes in adults as well as other diseases.

In the past, physicians primarily depended on their training. It doesn’t mean they didn’t use science to guide their decisions, but where and how physicians were trained influenced their treatment decisions more than research and science. That’s why EBM was developed; the use of solid evidence when considering treatment of patients keeps treatment up to date.

The problem is that the way EBM evolved appears to have excluded one of the primary purposes of how it began: consideration of the values and preferences of the patient. Treating patients should never be a one-way street. Your doctor should be a trusted advisor, not a dictator, and should give you the most up-to-date options for treatment of your condition; then you decide together which treatment option fits your life. The clinical and research evidence guides the physician in what to do along with knowledge of your personal health history, but only in the context of what you want.

For example, if after discussing all the options, a patient decides an earlier death is preferable to extending life by taking medication and suffering horrible side effects, that’s a valid preference that the doctor must respect. Another example: if the patient’s life expectancy is less than 10 years or so, pain management may be a better option than joint replacement when all the ramifications of major surgery are considered. That kind of joint decision-making is what EBM is supposed to be all about.

Saturday I’ll look at the guidelines for HbA1c proposed by the American College of Physicians in light of EBM. It’s a Memo you don’t want to miss.

What are you prepared to do today?

Dr. Chet

 

Reference: Ann Intern Med. doi:10.7326/M17-0939.

 

A New Approach to HbA1c

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Type 2 diabetes is a significant problem in North America and it’s spreading throughout the entire world. The treatment standard has always focused on controlling blood sugar, especially HbA1c. Normal is less than 5.7%. For most individuals, reducing the HbA1c to under 6.5% has been the goal for pharmacologic treatment.

HbA1c is a protein found on red blood cells that indicates blood glucose levels over the past 90 days. It develops when hemoglobin, a protein within red blood cells that carries oxygen throughout your body, bonds with glucose in the blood. Think of it as the sugar you ate over the last three months getting stuck to your red blood cells; the higher your HbA1c, the worse your control of your blood sugar has been. For a prediabetic, that means your days of diabetes meds and finger pricks is getting closer. For a diabetic, that opens the door to many of the worst consequences of diabetes, such as heart and kidney disease, blindness, and nerve damage.

Recently, the American College of Physicians published new guidance statements for the use of medications for controlling HbA1c. A committee of physicians examined the data behind the current standards of treatment for four of the major physician organizations including the American Diabetes Association. In the simplest terms, they wanted to know what benefits or hazards occur when treating adults with type 2 diabetes with medications. Should the goal be to get the HbA1c as low as possible with drugs? Or should the individual be part of the treatment equation?

This is an important issue and the topic for this week. I’m going to review evidence-based medicine on Thursday. You can get the entire story by listening to the Straight Talk on Health on evidence-based medicine, normally available only to Members and Insiders; I cover the entire concept of how EBM began and what it was intended to be. For those of you who haven’t chosen a membership yet, get more info here.

What are you prepared to do today?

Dr. Chet

 

Reference: Ann Intern Med. doi:10.7326/M17-0939.

 

Happy Fat Tuesday!

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Today is Mardi Gras—in case anyone doesn’t know, Fat Tuesday is the literal meaning of the French term. It’s the final celebration before the period of Lent that culminates in Easter Sunday. Many Christians use this time to give up something they enjoy as a sacrifice. The idea is to reflect and focus on our spiritual self; no matter your beliefs, giving up something you enjoy to focus on your inner self is a good idea. This week, I’m going to talk about giving up three typical categories of food and drink: sugar, salt, and alcohol. What benefits could you gain in the 40 or so days of abstinence from these foods? What may be a healthier substitute?

Let’s start with sugar, and by that I mean cake, cookies, donuts, sweet rolls, pies, ice cream, and candy. These are the ultimate in refined carbohydrates. If you were to abstain from these foods for 40 days, several things could happen. First, your insulin levels would probably drop because you wouldn’t have high levels of sugar hitting your bloodstream. If you’re prediabetic, you might see your triglyceride and HbA1c levels decline. If you had a fatty liver, it would most likely begin to clear up.

What could you substitute that would be healthier? Berries, fresh or frozen, any type, and you could even put a tablespoon of whipped cream on them. The antioxidants and phytonutrients would be better than the refined sugar; fruit sugar is processed differently, so it would not affect your blood sugar. Second choice would be citrus, and third would be apples.

If you’re considering giving up something for the next 40 days or so, make sure it’s something you really enjoy and eat regularly. Paula has a friend from Montana whose father, years ago before every food was available year round, gave up watermelon every Lent. It has to be meaningful.

What are you prepared to do today?

 

Dr. Chet

 

Prediabetes: What Now?

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The messages this week have talked about the risk factors for prediabetes and how many people don’t know what they are. It’s time to change that, at least in those of you who read the messages. Please feel free to pass them along to anyone you feel might also be unaware.

How do you know if you’re actually prediabetic? It requires a blood test for a specific protein called HbA1c. This protein indicates the amount of sugar that’s been in your blood stream for the past 90 days. The number for your blood sugar might be . . .

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