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U.S. Suspends Study on Intense Blood Sugar Control After Increase in Deaths Among Type 2 Participants


Feb 8, 2008

After seeing an increase in deaths among type 2 participants, the National Heart Lung and Blood Institute (NHLBI) has halted the intense blood sugar control portion of its years-long study on controlling cardiovascular risks to people with diabetes.

Over a seven-year period, ACCORD (Action to Control Cardiovascular Risk in Diabetes) has tracked 10,251 people with diabetes (ages 40 to 84 at 77 U.S. and Canadian sites) who have heart disease, obesity or high blood pressure - factors that put them at increased risk of heart attacks or strokes.

A panel monitoring results of the study found that 257 patients undergoing intensive treatment had died over its course, versus 203 deaths among those receiving standard treatment. The difference of 54 deaths was 3 per 1,000 participants. Not only was that figure statistically significant, half of the deaths in the intensive-control group were from heart disease - which intensive control had been designed to avoid.

The agency is contacting type 2 patients who participated in the intense-control sector of the study to inform them that it has been suspended, and to recommend that they begin adhering to less stringent goals.

In one section of the ACCORD study, the NHLBI split participants into two groups. One group received intensive blood glucose control treatment designed to bring its members' average A1c down to 6%. The goal was reach A1c's that were as close as possible to those found in people without diabetes. Medications given to the intensive-control group included Avandia, Actos, Byetta, Precose and generic drugs. These were combined with dietary and exercise guidelines designed to drive down A1c's.

The other group was given less intensive therapy designed to help it achieve average A1c's from 7% to 7.9%. While not considered ideal, that range of A1c's is the average among people with diabetes.

Despite the concentrated effort that included daily testing, drugs and close monitoring by doctors, only half of the members of the intensive control group were able to achieve A1c's of 6.4% or less.

The increase in deaths calls into question a long-held assumption among researchers that lower blood sugar levels decrease the health risks of people with diabetes, especially through the reduction of vascular inflammation caused by high blood glucose.

Editor's Note: We will continue to track this story as researchers seek the causes of the unexpected increase in heart disease and mortality.


Categories: A1c Test, Blood Glucose, Blood Sugar, Diabetes, Diabetes, Heart Care & Heart Disease, Professional Issues, Type 2 Issues, Type 2 Medications



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Comments

Posted by Ladybird on 8 February 2008

The "long-held assumption among researchers that lower blood sugar levels decrease the health risks of people with diabetes, especially through the reduction of vascular inflammation caused by high blood glucose." will probably prevail and many of us diabetics think that's the way it should be, as much of the medical community does also, even though, the ADA may be recommending the higher A1c's.

Dr M. Bortz in his book "Diabetes Danger" (2005)explains very clearly how the Diabetes epidemic around the world has occurred in the last 50 years. Very plainly put, by eating "super sized" meals and then becoming sedentary people, leading to weight gain, which leads to "increased fat deposits in the body fat stores, in the muscle cell, in the liver and in the beta cells of the pancreas...Higher blood fat levels decrease glucose utilization, which in turn leads to higher blood sugar levels. We know that physical exercise has major effects on every step of the ...sequence and effects blood glucose utilization and storage. It promotes insulin sensitivity and increases the sensitivity of muscle cell glucose transporters..."

I, as many diabetics wonder why doctors don't explain the above more clearly to patients, when they are able to catch them at the Pre-diabetic or early stages and encourage a lifestyle change of adding regular exercise and a "healthier" way of eating instead of putting people onto oral medicines, as soon as they walk into the clinics.

If doctors would do this more instead of just handing out prescriptions out, maybe we could have a less of an increase of this epidemic. Prevention studies have been done and all have come out with the conclusion that this IS the best way to go. It would cut tragedies like this when people die in studies supposedly to help them. Many doctors understand this and yet thousands of diabetics go onto medicines without being explained all the side effects of them.

We are talking about the broken down health system in the US, wouldn't this way be cheaper for system as well as the patient? Or is the drug industry in charge, not only in this country but also in other parts of the world?

And how many times, did the patients in the intensive part of this study, actually see their doctors/or the people in charge of the study. I understand from reading another source that the intensive study patient had to test his/her blood several times a day, and if the results were not what they were supposed to be they had to do "whatever" they needed to bring them down. To me that sounds very cruel. Is that how studies are done these days? So the patients probably died trying to keep their sugar down. To me its tragic. Yes, the goal is to keep our A1c's down but at what cost? What was more important over here, the patient's health or the study itself trying to prove a point?

I think even more than the fact that the study decided to abandon this goal, what really comes out of this is that the managers of medical studies should see to the safety of the patient first. Did the patients on the intensive study have a doctor on call, were doctors constantly checking them? I understand from the other source ( Med Page today)that they were seeing their doctors at two monthly intervals? Is that enough for such a critical intensive therapy study? Isn't the debate exactly over this, the safety of too low A1c levels? Didn't the study want to prove that low A1c's are "safe" and healthier? Yes, but then didn't the patients need more monitoring?

I am Type 2 and am trying to lower my own A1c to a stable one of now below 6, am at 6.3 right now but I'm NOT on any medications. I strongly do believe that diabetic medications sometimes cause more problems for those diabetics who could control their sugar levels better with a lifestyle change. Obviously, I'm not talking about Type 1's who need their insulin.

Forgive me for taking up so much space, but it's amazing to me to see how much money is spend on studies like this getting nowhere and killing people instead when it could be much better spent on educating diabetic patients on the importance of being in control of their own diabetes by making lifestyle changes.

Posted by Anonymous on 10 February 2008

Unfortunately the headline for this story is all wrong.

It should read "Higher Doses of Insulin Than Need Causes An Increase In Death Rates." The tight control group was achieving the tighter control through higher doses of insulin. Had they been achieving the tigher control through reduced carb intake and therefore reduced insulin requirements the outcome would have been the opposite of what it was.

Posted by Anonymous on 14 February 2008

I have type 2 diabetes. Just wanted to know if Mucinex Dm can cause my sugar to go up. It has . Just wanted to know what is in it that would do this?

Posted by Anonymous on 15 February 2008

It wasn't achieving "tight control" that was dangerous for these diabetics; many of them didn't even succeed. It was the manner in which they went about it. Pumping more meds into your system isn't the answer.

I have no doubt if these people had been eating a low carb diet, they would have succeeded in lowering their A1c levels with fewer or no meds.

I stopped taking meds a year ago and my last A1c was 4.9. It can be done with a healthy low carb lifestyle.

Posted by wifey on 15 February 2008

This sounds rather simplistic.
Perhaps this increase in death rate was caused by the drugs.
There should have also been a control group of patients who kept their HgA1c around 6 by exercise, diet, and insulin.

Posted by cgentry@dirtware.net on 15 February 2008

I think that there is no simple answer to the results, it is probably multiple factors, diabetes, family heart history and personal history. I'm type two, had a heart attack, on multiple insulins, eat low carbs., my father died at age 49. We are all struggling & learning, with the assistance of CDEs, MDs and the research community.

Posted by Anonymous on 15 February 2008

Hmmm... I'm not sure why my comment didn't make it past the moderator the first time. I'll try it again.

The problem with the study wasn't in achieving "tight control;" many (if not most) of the patients didn't even get under an A1c of 6. The problem was in how they went about trying to get there.

If the patients had been eating a truly low carb diet, they probably would have been able to achieve A1c levels under 6 with fewer or no meds at all.

I am a type 2 and stopped taking meds a year ago. My last A1c was 4.9. It is possible to achieve nondiabetic BGLs with a healthy low carb lifestyle.

Posted by Anonymous on 16 February 2008

I have mitochondrial diabetes. I use insulin several times a day. My latest AC1 was 6.4. No matter what the ADA says, I will continue to aim for a normal AC1. Do they truly want us (diabetics) to walk about with a blood sugar at 180,as recommended for a goal? This makes me so upset!!!

Posted by Anonymous on 17 February 2008

The management of type 2 diabetes is challenging.
In an ideal world, all Americans would:
1. eat a healthy diet that included fresh fruit & vegetables, low fat dairy choices, whole grains, and lean servings of protein (with chicken and fish more often)
2.avoid or limit consumption of processed and fast foods that often are high in calories, fat, carbohydrates and salt (visit CalorieKing.com to learn nutritional info about fast food restaurants)
3. have 30 -60 minutes of physical activity daily
4.be referred for lifestyle change counselling if there fasting blood glucose indicated pre-diabetes (fasting blood glucose 100-125 mg/dL)

In defense of primary care doctors, many discuss/encourage physcial activity and weight loss with their patients. As a certified diabetes educator, I have spoken with many frustrated physicians who have encouraged patients to make lifestyle changes to no avail. Often times when a patient is diagnosed with type 2 diabetes, it is not neccessarily that the doctor is taking the easy way out but many times it is easier to get a patient to take a pill once a day than it is to get a patient to exercise or change their eating habits.
I do have an open mind about lower carb diets and compliment those that are motivated and can limit their carb intake and have better blood glucose after meals. Just two points to consider, one it is important when lowering the carb intake that the individual is not shifting the diet to increase the amount of fat and protein because this can increase the risk of heart disease. Secondly, I have counseled many individuals on their eating habits. Many are relunctant to limit their carb intake to our recommmendations: less than 45grams a meal for women and less thab 60 grams a meal for men.
What I can say with absolute certainty is there are no easy answers and what works for one patient may not work for another.
It is important to look at the whole picture. We live in a country that eats too much and sits too much. We need to eat less and move more.And as an educator I know that it is easier said then done.
It is with a great sense of accomplishment, when I am able to motivate and support an individual to take small steps, one at a time towards making and maintaining lifestyle changes.

Posted by Anonymous on 17 February 2008

So ridiculous!

Posted by Anonymous on 18 February 2008

As a type II diabetic who has learned to manage my condition with a very low carb diet based on intermittent fasting the results of this study confirm what I suspected from the onset - the biggest obstacle to your well-being and ultimately your very survival may be your family physician.

Posted by catman on 18 February 2008

That the researchers admit they are mystified by the results the message to diabetics is "be afraid, be very afraid of your health care professional".

Posted by catman on 20 February 2008

To the anonymous party who made the following statement I respectfully suggest that if you really do have the best interests of your patients in mind that you devote some serious time to researching the science behind the high fat hypothesis. If you so you will find none. A moderate or high fat diet is by default a high carbohydrate diet. By default a high carb diet produces high amounts of the worst possible fat. It is carbs that are the problem. Refined vegetable oils are also toxic.

"Just two points to consider, one it is important when lowering the carb intake that the individual is not shifting the diet to increase the amount of fat and protein because this can increase the risk of heart disease."

Posted by Anonymous on 28 February 2008

Obviously we need more info on these results. As a diabetes educator I taylor my teaching to the individual person. A 75 year old with multiple health issues has no business risking deadly hypo reactions trying to get a blood sugar to 80, and an active 40 year old certainly should. I really agree with the opinions which claim is was not the blood sugar but how it was achieved (more medication) I see pts on so much medication I know the body cannot be absorbing all of them, and what is the combination doing? This country is in trouble and over medicated but also personal responsiblity is seriously lacking. Poor diet, no exercise is the norm all the way down to our kids. We are fast becomming the most unhealthy modern society in the world.


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