High Carb T2 Diabetes Trial Ends in Failure

[Superchip]

Thanks borofergie, great post.
I've printed off two of the articles from the NY Times and shall present them to the DN at the next appointment fiasco.

Dillinger, excellent response, haha why let the truth get in the way of a damned good backhander ?

Regards

[borofergie]

It seems to me that the experiment is so badly flawed that it would be very hard to draw any solid conclusions from it. It is a huge waste of time and money. I doubt if the experiment will ever get published in a reputable journal because the design of the experiment is so poor, and so it will not get through peer review.

I don't accept it's flawed. It's testing the influence of the standard intervention recommeneded by organizations such as the ADA, NHS and DUK. I think that's a much better use of money than looking piecemeal at seperate interventions and then deciding that they don't all work together. Anyway, you could consider diet + exercise as a single intervention, set up to deliver a calorific deficit.

I think that we can derive some very solid conclusions from it:

“We were hoping that a weight-loss program would help reduce cardiovascular disease, but now we have the answer that it doesn’t,” said Mary E. Evans, a physician at the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, which paid for the study.

But the outcome is clear, said Dr. David Nathan, a principal investigator and director of the Diabetes Center at Massachusetts General Hospital. “We have to have an adult conversation about this,” he said. “This was a negative result.”

No-one spends $200m on a study and then fails to get it published in a peer reviewed journal.

[Patch]

But the outcome is clear, said Dr. David Nathan, a principal investigator and director of the Diabetes Center at Massachusetts General Hospital. “We have to have an adult conversation about this,” he said. “This was a negative result.”

This is a huge step forward.

[xyzzy]

So it's a 55% carbohydrate diet, exactly the sort of thing advocated by the NHS and DUK.

I dare say they'll now spend another $200m and take another 11 years to determine what could possibly have gone wrong with the parameters of the study and then do the same thing all over again rather than simply spot that number 55 as the cause.

The NHS DUK ADA etc have so much vested interest in making that high carb exercise message work they are certainly not going to undermine their own message as its the one that their political masters want to continue. It is far less damaging politically to blame "fat and lazy" people than actually accept the alternative and confront the real issues such as the leverage the food and drinks industry has over health policies world wide etc.

Despite feeling vindicated over my own personal low carb choices and the benefits I've seen ensue from making that choice I don't expect any changes will come of this anytime soon.

Anyone who is getting the starchy carb and exercise with every meal mantra form their doctors, dsn's and dietitians should print the conclusions out and take them to their next consultation as ammunition and ask them why they are being recommended to do things that have been shown not to work.

[borofergie]

What do we actually know?
At year eleven the trial was stopped. (this seems to be according to the procedure described in the protocol ;ie they described the circumstances that would stop the trial from the start(
This was during the follow up so by then very much reduced intervention.
there was no difference in CVD events
The 'lifestyle' (intervention) group used fewer medications than the DSE (control)group.
Overall in the lifestyle group there was a 5% reduction in weight.

What we know:

1. Moderate weight loss does not reduce cardiovascular disease.
2. An NHS style diet and exercise intervention does not improve mortality in T2 diabetics and the obese.

(1) alone is worth $200m. As Jaminet says, it points clearly to the fact that obesity does not cause health complications, but that obesity and health complications are both symptoms of a common third factor.
(2) Now that we've proved that high-carb/low-calorie+exercise doesn't work, we can go on to discussing other interventions that probably do work.


Reduced medications and weight-loss are very nice, but almost completely besides the point, if they don't improve outcomes, and they don't stop people dying then frankly, who gives a damn?

I'd put my diabetes into remission within weeks of being diagnosed, when I was still very obese (I still am technically obese). My weight dropped naturally as a result of my own low-carb intervention, which to me is a further illustration that obesity is a symptom, not a cause.

What we don't know (though it's amazing how many people seem to think they can say what happened with zero information)
What was the drop-out level?... how many were attending the monthly sessions at the end?
Was there a difference in outcomes between those that continued to attend/ sustained larger amounts of weight loss and the drop-outs?
TBH until you know that then all speculation is useless
[/quote]

It's all nice information, but it won't change the verdict:

“We were hoping that a weight-loss program would help reduce cardiovascular disease, but now we have the answer that it doesn’t,” said Mary E. Evans, a physician at the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, which paid for the study.

But the outcome is clear, said Dr. David Nathan, a principal investigator and director of the Diabetes Center at Massachusetts General Hospital. “We have to have an adult conversation about this,” he said. “This was a negative result.”

Time to move on, on the whole "50% carbs for diabetics" thing don't you think?

[xyzzy]

It seems to me that the experiment is so badly flawed that it would be very hard to draw any solid conclusions from it. It is a huge waste of time and money. I doubt if the experiment will ever get published in a reputable journal because the design of the experiment is so poor, and so it will not get through peer review.

I do hope it will get published and like others I don't accept that the experiment was flawed. In fact it has produced results entirely inline with what many of us who have successfully controlled our T2 would expect. The trouble is people like us are never asked how do we control our conditions successfully.

If you are newly diagnosed then in most cases controlling your T2 is quite straightforward just cut out most sugar and cut down on starchy carbs (rice, pasta, bread, potatoes, cereals and other flour based products) and replace with extra meat, fish, cheese eggs and especially green veg. A lot of T2's end up finding the control point is somewhere between a 10% and 30% carbohydrate diet depending on how much insulin resistance they have and how much pancreatic function remains. Get and use a meter to work out your personal tolerance. It's not rocket science and certainly doesn't cost $200m and 11 years to prove.

[hanadr]

This failed study, has shown that their partcular recommended lifestyle modification doesn't work, However it's still a HUGE leap to the humility needed to look at a controlled carb lifestyle.
Of course, the fact that exercise doesn't do much for weight has been known for decades and they still peddle it as an answer.
Even more useless is "moderate" exercise! Extreme exercise does affect weight.
Hana
PS who's going to send the reference to DUK. I'm just off away for a few days.

[Defren]

I hope they publish the body counts.

It's this kind of thing that really concerns me. Not that you wonder if they will publish a body count Stephen, but the fact there will be one. Posters here know that now and again we have television programs come along and ask us if we would be willing to take part in a new show they have in the planning. I always refuse, simply because I have worked out what suits me, so why would I change that for a diet that could possibly harm me.

The people who took part in this trial, possibly knew nothing about a low carb diet and diabetes, so will have gone into this trial thinking it may help them, when as we can see 11.5 years later, there is a body count. There is not a shread of doubt in my mind, had these people trialed a low carbohydrate diet, many would still be alive, AND healthy.

While we all accept things are only found out by trials etc, the high carb low fat diet has been shown over and over not to work, so why the need to through 220 million at it? My GP wants to do a trial of low carb diabetics, he is certainly not asking for anything near £220 million, but I will lay odds he won't get a penny!!

[xyzzy]

The people who took part in this trial, possibly knew nothing about a low carb diet and diabetes, so will have gone into this trial thinking it may help them, when as we can see 11.5 years later, there is a body count. There is not a shread of doubt in my mind, had these people trialed a low carbohydrate diet, many would still be alive, AND healthy.

Excellent point Jo +1 and all that

[borofergie]

It's this kind of thing that really concerns me. Not that you wonder if they will publish a body count Stephen, but the fact there will be one.

Well to be fair, in any trial of this magnitude people will die. That's kinda the point, these trials are body counting exercises (to prove that the intervention kills more people than the control group). To be fair to the researchers, they thought they had designed an intervention that would save lives, and their sense of disappointed is almost tangible from the quotes that they made in the press.

However, we all know, that the mortality rate would have been much lower, had the intervention been a supported low-carb diet.

We'll get there in the end.

[IanD]

I complete 12 years as a T2 diabetic. I'm now 73 & fit, well & active.

During those 12 years I have personally conducted 2 diet/exercise routines:
DUK high starchy carb/low fat-sugar-salt, with regular exercise - mainly tennis. 8 years of that & I was becoming crippled & could not exercise. My active life was over - it was a painful struggle to get out of bed.

Then I found this forum, & switched to low carb, with fats as they come. 3 months & I was out of pain & playing tennis again, & 4 years on I am fit & well, & playing tennis at club standard still.

I have no intention of abandoning my low carb diet & exercise programme.

Ealing Hospital have a cardio rehab exercise class - 2 sessions a week intended to benefit cardio patients (I go with my wife who had a heart attack 10 years ago.) We have progressed from simple circuit training to include table tennis & badminton. That exercise is certainly beneficial, with a friendly club atmosphere. Everybody's fitness is visibly enhanced.

[xyzzy]

A bit more of the original announcement can be seen here

http://webcache.googleusercontent.com/search?q=cache:1k9II8ZwOyMJ:www.theheart.org/article/1458351.do+&cd=1&hl=en&ct=clnk

Of great interest is the main thing that didn't change between the group that were on the low fat, high carb exercise regime and those who weren't was the fact that BOTH groups had similarly bad LDL cholesterol levels after the 11 years.

The only cardiovascular risk factor that remained unchanged with treatment was LDL-cholesterol levels.

What is even more galling is they've wasted 11 years and 200m replicating results that were already known. See a posters comments lower down the page.

This is not new, we saw it in MR FIT in 1982 found no significant CV benefit and no overall benefit from intensive lifestyle intervention. The Goteborg Study published in 1986 also demonstrated no benefit.

I would suggest that from this it implies a low fat, high carb with exercise regime raises your bad cholesterol levels but I'm sure that must be wrong

As someone who adopted a low fat high carb diet with exercise regime for many years prior to diagnosis of T2D and screwing his LDL level I can agree with that finding...

[borofergie]

Hah - got there at the same time as BlindDog:

The Action for Health Diabetes (Look AHEAD) study, a trial comparing an intensive lifestyle-intervention program aimed at achieving and maintaining weight loss and fitness in patients with type 2 diabetes, has been stopped for futility.

A large cardiovascular-outcomes study funded by the National Institutes of Health that included 5145 adults with diabetes and a body mass index >25 kg/m2, Look AHEAD failed to show a difference in the rate of nonfatal MI, nonfatal stroke, death, or hospitalization for angina among patients randomized to an intensive lifestyle intervention and those randomized to a control arm consisting of education alone.

Despite significant reductions in weight and improvements in physical-fitness levels among patients with diabetes, investigators concluded that the intervention arm, which included individual sessions with a nutritionist and/or personal trainer, as well as group sessions and refresher courses, failed to provide any benefit in terms of cardiovascular outcomes.

Here is the earlier report which mentions the unchanged LDL levels:
http://care.diabetesjournals.org/content/34/7/1481.full

The improvement in HbA1c was marginal too:


Only those that approached 15% weight loss got anywhere near reducing their HbA1c by 1%, most were nearer to 0.5%. By comparison, I achieved a 5.7% reduction in HbA1c (for 10.6% to 4.9%) by low-carbing.

[xyzzy]

Hah - got there at the same time as BlindDog:

Here is the earlier report which mentions the unchanged LDL levels:
Only those that approached 15% weight loss got anywhere near reducing their HbA1c by 1%, most were nearer to 0.5%. By comparison, I achieved a 5.7% reduction in HbA1c (for 10.6% to 4.9%) by low-carbing.

Thanks for the links Stephen appreciated.

As you say 0.5% in 11 years - wow what a result - not

It's not difficult is it?

I did 11.3% to 5.3% or a 6% drop in 3 months by adopting a low carb higher fat diet .
I went from a just under 6 on statins total cholesterol to a 3.9 off statins result by adopting a low carb higher fat diet.
I went from a BP of 145/95 to 115/75 by adopting a low carb higher fat diet.
I lost 3 stone in 6 months on a low carb higher fat diet.

Unlike yourself (no criticism at all) I did it all by doing no more exercise than I had been doing prior to diagnosis.

Low carb boring? I don't think so. Mrs xyzzy's latest. Low carb pasta made from Soya flour and Vital Wheat Gluten. The plateful is uncooked and is less than 20g of carbs in total.

lcspag.jpg (52.39 KiB) Viewed 612 times

[phoenix]

The trial was about losing weight, and whether that would result in fewer incidences of CVD. Some lost weigh but not I would suggest enough. There are other trials showing greater weight loss initially, though very few over a long period.

I think the trial shows the problem of trying to change a large number of peoples weight and whether in fact it will make a difference!

Would they have done better on a different type of diet; who knows? It is not sensible to try to compare them with a few people on a forum .
I can tell you of a few individuals who have had CVD 'events' heart attacks or the necessity for stents and a couple who have died on this and other forums (including those who adopted very low carb diets and those who haven't ). I could personalise as so many have done (cholesterol decreased from over 8mmol/l at diagnosis, regression in plaque and greater blood flow rate at seven years ) but important as this is to us as individuals it isn't hard data.
There are so many people that don't continue to post ,we don't know their outcomes over a year; let alone 11 years.

I think the very small 44 month non-randomised low carb trial actually showed an increase in weight at 44 months but haven't checked, is there a longer one? There were CVD events in that trial too.


Jaminet may have blogged about it but he also (subsequently or before he wrote) seems to agree that we don't have enough info

Paul JaminetOctober 22, 2012 11:39 AM
Good point about the change in weight vs outcomes, that would be interesting. Hard to say anything about this trial based on the press releases and news stories. I haven't seen any useful data yet

http://carbsanity.blogspot.fr/2012/10/t ... mment-form

Just realised that she has written a second post about it, I haven't read that yet.
Well, I've skimmed it now, you might want to read both posts. and comments,
This is one from Guyenet. I find it interesting that he says that there were fewer events than expected.

Stephan GuyenetOctober 23, 2012 12:46 PM
A 5% weight loss can be clinically significant even if it's not aesthetically significant. The DPP and related trials had similar weight losses and they prevented diabetes incidence by up to 60%. This was basically a follow-up study to DPP and there was every reason to believe the intervention would be effective based on previous trials.

The reason Look AHEAD was terminated early is that it was hopelessly underpowered. The event rate was nearly 4X lower than expected. It's still possible that the intervention would have been highly successful, but we'll never know because the study design turned out to be inadequate. Still, they found improvements in several secondary endpoints.
http://www.drsharma.ca/looking-back-at-look-ahead.htm

and the Sharma link gives more details .

This reduction in body weight was accompanied by significant improvements in glycemic control and numerous other health benefits (e.g. decreased sleep apnea, improved mobility and quality of life)

given a remarkably low incidence of ‘hard’ endpoints in both the interventions and control groups, it became evident the the study would stand little chance of demonstrating superiority of the lifestyle intervention in terms of preventing cardiovascular complications.

Nevertheless, according to the recommendations of the Data Monitoring Board, the study should be continued (without the intervention) to determine the long-term outcomes in the participants.

and a suggestion:

Not only may future studies have to enrol a substantially greater number of participants but such studies may also need to substantially enrich the study population with higher risk individuals to increase event rates (i.e. EOSS Stage 3 rather than just EOSS Stage 2 patients).

Storm in a very expensive tea cup?