Tag Archive for: type 2 diabetes

What Is Secondary Prevention?

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Secondary prevention encompasses a wide range of health-related conditions. It includes people with risk factors such as high cholesterol and blood pressure, cigarette smoking, elevated HbA1c, atrial fibrillation, and more. It also includes people who may have had a heart attack, stroke, cancer, or were treated and now are trying to prevent a recurrence of another incident. This all falls under the umbrella of secondary prevention.

The problem, as I see it, is that we don’t take the risk factors seriously enough to prevent the occurrence of serious health events. For example, let’s say a person gets a reading of 5.9% in an HbA1c reading. That’s considered pre-diabetic and is definitely on the path to type 2 diabetes. The solution is pretty straightforward: reduce refined carbohydrate intake and total caloric intake if the person has weight to lose. Then start an exercise program and stick to it.

Did you know that within three days of beginning a walking or exercise bike program, your body will begin to utilize insulin better? That’s how quickly your body reduces insulin resistance and starts the path back to a lower HbA1c and thus reducing the risk of type 2 diabetes.

Aging with a vengeance is all about prevention—primary prevention to prevent serious diseases and conditions from occurring in the first place and secondary prevention to deal with them if they do occur. Aging is a risk factor in and of itself but not because of a calendar; it’s the changes that naturally occur as we age. What we do to resist or delay those changes is at least partly in our hands. That’s why I said aging with a vengeance begins in your 30s and maybe even younger.

It all begins with six simple words: Eat less. Eat better. Move more. I’ll continue to comb the research to find strategies to deal with other issues. Next week, I’ll review a research study that reveals the secret to getting results.

What are you prepared to do today?

        Dr. Chet

It’s Official: Prescription Fish Oil

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The U.S. Food and Drug Administration approved the prescription fish oil Vascepa for expanded use on Friday, December 13. The approval for the medication is for the secondary prevention of cardiovascular disease in patients under the following conditions:

  • Triglycerides above 150 mg/dl for everyone with diagnosed CVD and taking a statin medication.
  • Diabetes and two or more additional risk factors for CVD along with taking a statin medication.

The modifiable risk factors for CVD include smoking, obesity, high cholesterol, hypertension, and sedentary living. Remember from our prior series, secondary prevention may help reduce the risk of CVD symptoms developing.

My concerns are the same as they were before. Triglycerides less than 250 mg/dl can be resolved by diet and exercise in most people. Because the mechanism of action is unknown as to how the prescription works, there’s no reason to think that reducing triglycerides by lifestyle change won’t work as well as the prescription; the clinical trial didn’t track this data.

Speaking of lifestyle change, keep in mind the website specials on the Optimal Performance program as we get ready for the New Year. The Basic Meal Plan will teach you how to change your diet to reduce triglyceride levels if your levels are too high.

What are you prepared to do today?

        Dr. Chet

References:
1. http://bit.ly/36EbsYK
2. N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

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.

Prescription Fish Oil: Questions Remain

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The REDUCE-IT clinical trial formed the basis for the expanded recommendations for use of Vascepa, the prescription fish-oil medication. This was an expensive trial, involving 11 countries and hundreds of medical centers with 999 physicians who recruited subjects, collected data, and kept track of the subjects for close to five years. With over 8,000 subjects, this was no easy task. As I said in Thursday’s Memo, they examined the primary and secondary prevention when the medication is taken with statins versus a placebo with statins.

While this was a tremendous effort, there are still some concerns, in my opinion.

Study Concerns

A board made up of physicians and the pharmaceutical company’s staff designed the study and helped execute it; the pharmaceutical company paid for the clinical trial, collected and managed the data, analyzed the data, and interpreted the results. Then the statistics were reviewed by an independent statistician. This creates a huge conflict of interest regardless of safeguards that may have been put in place.

When any type of study is supported by companies with vested interests in the outcome, there will always be questions. That has been true for every dietary supplement manufacturer that’s ever funded a study as well as the milk and sugar industry. It’s especially true for this study. I began by talking about a report from the financial sector. Billions of dollars are on the line. That has to be considered by the FDA before final approval is given.

I have a tendency to have faith in science, as skeptical as I may be at times. And that’s where my concerns lie; not in the financial aspect but in the study design and results.

My Concerns

As complicated as this study was, it was incomplete in my opinion. They did not collect any data on the subjects’ diet; a small change in diet could have reduced triglycerides (TG) enough to have a positive impact on secondary outcomes. The median change in TG over five years with the medication was 45 mg/dl, from about 215 down to 170 in the medication group, while it was reduced 13 mg/dl in the placebo group. We don’t know whether a group that focused on dietary changes to reduce TG would have the same reduction in CVD events; that would have been an excellent addition to the study design.

They also didn’t have a group using fish oil from dietary supplements. True, it’s not their responsibility, but we can’t know whether the same benefit might not occur if the dosing of EPA were equal:

  • Almost every study that has used fish oil to examine whether CVD outcomes could be reduced has used fish oil with 1 gram of EPA.
  • If the amount of EPA were the same, a head-to-head comparison between a supplement and medication that each had 4 grams EPA might have found a similar benefit.

The real issue is that we don’t know what makes the fish-oil medication work, just like we don’t know completely how dietary omega-3 fatty acids work. Is it just the reduction in the TG or how the oils work in the body? Are genetics involved? Diet? The microbiome? We have no idea at this time.

The Bottom Line

I’ll keep on eye on the approval process for this fish-oil pharmaceutical and let you know how it will be prescribed in the future. The decrease in TG found in the study can be done with lifestyle changes alone, so is it going to be worth the cost of a pharmaceutical for a slight reduction in CVD events? Remember the difference between medication and placebo was just 4.8%. If you fall in that category, you’ll have to decide for yourself: pharmaceutical fish oil or lifestyle change. In this case, a little work may go a long way.

What are you prepared to do today?

        Dr. Chet

P.S. This will be the last Memo until after Thanksgiving. Paula and I are doing something we haven’t done in 20 years: go on a real vacation, just us, just for fun. No work of any type. Talk to you again December 3.

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Primary vs. Secondary Meds

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One of the key questions for the FDA advisory panel to consider was whether the prescription fish oil was a primary preventer of cardiovascular disease or a secondary preventer. What’s the difference? Primary prevention of CVD would impact the disease and stop events before they occurred in the subjects taking the fish-oil medication. Secondary prevention would prevent additional CVD events from happening in those with established CVD.

If you were a type 2 diabetic with an additional risk for CVD such as obesity or being a smoker, taking the prescription fish oil with a statin would prevent a heart attack or stroke from happening; that’s primary prevention. Based on the Reduction of Cardiovascular Events with Icosa-pent Ethyl–Intervention Trial (REDUCE-IT) that didn’t happen, but it did prove to be a secondary preventer of additional cardiac events in those subjects in the study with established disease.

The question is whether the FDA will approve the prescription fish oil as a primary prevention or a secondary prevention pharmaceutical. The advisory panel seemed split on that count. The assumption by some was that there was disease present even though the event had yet to occur. Others said “prove it” by doing an actual clinical trial to examine that question. We’ll find out how the FDA decides later this year. As I mentioned yesterday, the financial implications are huge.

There are still some things to consider with the clinical trial, and I’ll cover that on Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Prescription Fish Oil Update

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“This Fish-Oil Heart Drug Could Be Big, Could Be Huge.” That was the headline in a well-known financial report after a Food and Drug Administration panel unanimously voted in favor of an expanded use for the prescription fish-oil drug. I mentioned this was a possibility when I first talked about Vascepa in October. The FDA is expected to make a final decision by the end of the year.

What is the expanded use? The medication could be prescribed to those who have established heart disease or type 2 diabetes with another CVD risk factor and are already taking statin medications to lower cholesterol. The advisory panel approved the use because research showed that when combined with statins, it could reduce CVD endpoints such as death, heart attacks, and strokes by an additional 4.8% when compared to a placebo over a 4.9 year follow-up period, 17.2% versus 22%.

One more thing. The medication could be prescribed to those with triglycerides as low as 150 mg/dl. That would include millions more potential users in the U.S. and Canada alone. You can see why the headline was in the financial news; the potential profit for investors could be huge. A lot is riding on what the FDA decides. I’ll explain that on Thursday.

What are you prepared to do today?

        Dr. Chet

Reference: Bloomberg Online. Max Nisen. Posted 11-15-2019.

News on Food as Medicine

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As a conventional medical journal and one of the leading medical journals in the world, The Journal of the American Medical Association doesn’t often publish reviews of the impact of food on health. However, a recent edition of the Journal included a summary of three such studies, and that’s the topic for this week.

The first study examined whether mushrooms, which are full of vitamins, minerals, and phytonutrients, decrease the risk of cardiovascular disease (CVD) or type 2 diabetes (T2D). The researchers re-analyzed the data from the Nurses’ Health Study and the Health Professionals Follow-up Study. When they compared more than five servings of mushrooms per day with less than one serving per day, they found no differences in the rate of symptoms or markers associated with CVD or T2D. One interesting note was that if mushrooms were substituted for meat, there was a decreased risk of T2D.

This is one of the first studies to acknowledge the problems with nutrition data in these types of studies. The data on mushrooms were only collected at the beginning of the studies; that doesn’t allow for comparisons over time. Further, the questionnaire didn’t allow for data on a variety of types of mushrooms. The best observation at this point is that we don’t know whether mushrooms or specific types of mushrooms are beneficial for reducing the risk of disease until more research is done.

We do know they’re good for you, so enjoy your mushrooms; sautéed mushrooms are a great addition to many dishes. Here’s another way to enjoy mushrooms: Creamy Mushroom Soup from the Health Info page at drchet.com. Check out the other recipes while you’re there.

We’ll look at another study on Thursday.

What are you prepared to do today?

        Dr. Chet

P.S. Don’t forget to complete the survey on Dr. Chet’s Traveling Health Show. I could be coming to a city near you in 2020! Click the link below to go to the survey.

Survey

Reference: AJCN https://doi.org/10.1093/ajcn/nqz057.

What Would You Invest in a Healthier Diet?

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Would you eat more vegetables and fruit if your health insurance paid for it? How about an overall healthier diet that also included whole grains, nuts and seeds, fish, and healthy oils? Would you eat healthier if it didn’t cost you more?

Researchers from Tufts and Harvard examined the potential cost and benefits of subsidizing 30% of the costs of both approaches in Medicare and Medicaid programs. This was a computer simulation using data from NHANES on dietary intake and the relationship to cardiovascular disease and type 2 diabetes. They used the CVD events and mortality data and the current costs of treatment. Then they created models, one with increasing vegetable and fruit intake and another increasing all the aforementioned food, to find out if a healthier diet would affect disease events, deaths, and costs associated with the treatments.

Their estimates found that over a lifetime, the vegetable and fruits model would prevent 1.93 million CVD events and 350,000 CVD deaths while saving $40 billion in healthcare costs. The healthy food model would prevent 3.28 million CVD cases and 620,000 CVD deaths, prevent 120,000 diabetes cases, and save $100 billion in healthcare costs.

However, the net cost of the first model—subsidies minus healthcare savings—would be $84 billion while the second would cost $111 billon. It would improve the quality of life, but at a price. It’s easy to get lost in big numbers so let’s bring it down to the individual. After deducting healthcare savings, it would cost $110 per person per year for the fruit and vegetable subsidy and $185 per person per year for the healthy foods model. Does that seem like a reasonable investment for a healthier life for everyone?

The unknowns are whether physicians would actually write the prescriptions for foods; they’re not known for their nutrition knowledge and have a tendency to look for a pharmaceutical solution. But I think that’s minor; the real unknown is whether people will actually buy healthier foods and eat them.

We’ll find out: $25 million has been set aside in the 2018 Farm Bill to run pilot programs. It will be years before we know the results, but it’s a start to see if the theoretical will meet the actual.


The Bottom Line

Using food to improve health and quality of life makes sense. Whether having insurance companies or government pay 30% for healthier foods will work, I’m not convinced. I get the reduction of CVD events and deaths that could potentially be saved and the reduction in healthcare costs, but I question the $100 billion price tag without a public health education program to go along with it. Maybe a better approach would be to invest in the public health education program to teach people and physicians how they can use food to be healthier.

But now you know how a healthier diet could affect your life. What are you prepared to do today?

        Dr. Chet

Reference: PLoS Med 16(3): e1002761. https://doi.org/10.1371/journal.pmed.1002761.

Triathlon Observations: Prepare to Compete

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Let me be clear: I think that the single most important thing that you can do to be healthy is to exercise regularly. Whether walking, swimming, or one of the hundreds of other types of exercise, talking with your physician about it may be all that’s required for you to get started.

Moving from exercise that helps your health to competing in fitness events requires more—that’s independent of your body weight lest you think I’m talking only about the very heavy people that competed in the triathlon. Here’s what I recommend.

First, you should have a stress test that assesses how your heart and blood vessels perform under maximal conditions. That applies to men over 40 and women over 50, for sure. But I also think if you have been overweight for over five years, you should have the test regardless of age. The maximal exercise test is not foolproof, but it’s the best available predictor of heart problems. This isn’t just me being a worrier; I’m sad to report that one participant died of a heart attack last Sunday. Getting checked out before you start is the best way to protect yourself.

Second, you should have a complete lipid profile, HbA1c, and a blood insulin test as a minimum. As I suggested in Thursday’s memo, you need to know whether you’re a prediabetic or even an undiagnosed type 2 diabetic. The best option for you would be to exercise, but when you push yourself hard for long periods of time, it’s going to affect your blood sugar levels as it would affect a diabetic’s, not someone who has a normal carbohydrate metabolism; for instance, you could pass out if your blood sugar gets too low, and if you’re out alone on a run, that’s a problem. You can deal with it, but you have to know if it’s an issue.

Third, you should get an orthopedic analysis. By that I mean that your joints should be evaluated for range of motion, tendon and ligament stability, and gait. Swimming affects the shoulders, bicycling the lower back, and running the hips, knees, and feet. Any abnormality will be exacerbated; for example, the forces you create when you run is five times your body weight. Do the math—that’s a lot of stress on your knees and feet.

Once you get the all clear, get after it. Start conservatively but if you have the urge to compete to see what you’re capable of, do it. I think if you want a challenge, whether to walk or run a 5K, swim a mile, or bike 50 miles, or combine them into a single event such as the triathlon, you should do it. Just make sure you get your body checked out before you do.

Final Observation

While I believe exercise is important no matter the level at which you do it, exercise won’t help you lose a lot of weight. Surprised? Remember the size of the people I mentioned that competed in the triathlon—not just overweight but obese? If they had put in the training, and I know some of the competitors and know that they did, you’d have thought they would have lost a significant amount of weight. They didn’t.

Burning calories helps with weight loss, but as a well-known expert once said “Americans can’t out run their appetites.” If you could exercise six or eight hours a day, you could probably lose weight without changing your diet, but I doubt you have that kind of time. You can use exercise as a tool to help you lose weight, and exercise pays major benefits in fitness, strength, and stamina. But you will not lose weight unless you also eat less and eat better.

What are you prepared to do today?

Dr. Chet

 

Sugar vs. Sweetener Research: Meaningless in the Real World

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I’m in a slight disadvantage in evaluating this study; I was able to read only the convention-session abstract and the press release. There were no recordings of the presentation that I could find, so there are details I don’t know. I have questions about the process, not the results, so here are my thoughts.

The In-Vitro Study

If you’re not familiar with the lingo, time to learn. In vitro is Latin, meaning literally “in glass.” An in-vitro study is conducted in a Petri dish, a test tube, or some location outside of an entire animal or human.

In this study, researchers exposed endothelial cells from the rats’ arteries to sugars and artificial sweeteners. We know there were changes in proteins; what we didn’t know is whether the change in protein genes that were activated in response to the artificial sweeteners mimicked a pattern we might see in a rat that’s diabetic. That’s an important question.

It would have been more meaningful if they examined a pattern of protein responses that occurred in the endothelial cells of rodents that already had diabetes. Just because something is activated in response to a stimulus, in this case sugars or artificial sweeteners, that doesn’t necessarily mean it’s a bad thing. It just means it happened.

The In-Vivo Study

In vivo is also Latin and means within a live animal or human. I have several issues with the rodent part of the study. First they gave high levels of sugar to the rats as well as high levels of artificial sweeteners. It would seem to me that it would be beneficial to get an estimate of what humans actually consume on a daily basis, dose it down to the appropriate amount for a rat, and start with that. Then you can compare your test results to a “normal” level. Next you can begin increasing the amount to see when the negative effects begin.

Second they used the DR/BB rat; DR stands for diabetes resistant and BB stands for biobreeding. This type of rodent is often used for research on type 1 diabetes because although it’s diabetes resistant, it has an underdeveloped immune system. It will respond to environmental insults differently than normal rats. Excess levels of sugar and artificial sweeteners may create an insult to the immune system to cause type 1 diabetes in this breed of rat.

The reason for doing the study was to see if artificial sweeteners may be contributing to the obesity and diabetes epidemic—type 2 diabetes, not type 1. Using this breed of rat seems like it would muddy the results. The changes they found in the blood of these rats fed excessive amounts sugar and artificial sweeteners would have been expected. The question is whether this is related directly to the research hypothesis or not. In my opinion, no.

To make this study pertinent to humans, we would need a similar pattern found in humans. Perhaps people under excessive stress and whose immune systems were compromised might show some relationship. But we’re not talking about susceptibility to type 1 diabetes. We’re talking about type 2 diabetes, and although they share a name, they’re vastly different diseases.

What we have is a study in test tubes on protein genes that are activated in response to artificial sweeteners and a second study on rodents with some dysfunction in over 200 different protein genes in response to sugar and artificial sweeteners. We may have people who use excessive amounts of artificial sweeteners everyday. We may have specific but as yet unknown gene patterns that may make people more susceptible to type 2 diabetes, but we haven’t identified what those genetic patterns are at this point or even if they exist at all.

The Bottom Line

So what does this study mean? This basic research shows that there may be a pattern to protein synthesis that’s different in high-sugar versus artificial-sweetener intake. But that does not resemble in any way what the authors of the study suggested in the press release. This study is relatively meaningless in the real world. Maybe we’ll know more about how all this impacts humans in another 5–10 maybe even 20 years. But as of today, it’s just provocative headlines. And we get far too many of those already.

Use artificial sweeteners or do not; that’s your choice. But don’t change based on this study. Use the old adage: everything in moderation including moderation.

What are you prepared to do today?

Dr. Chet

 

Reference: EB 2018. The Influence of Sugar and Artificial Sweeteners on Vascular Health during the Onset and Progression of Diabetes Board # / Pub #: A322 603.20.