AlanC said: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.
borofergie said:I hope they publish the body counts.
Defren said: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.
Defren said: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.
The only cardiovascular risk factor that remained unchanged with treatment was LDL-cholesterol levels.
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.
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.
borofergie said: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.
http://carbsanity.blogspot.fr/2012/10/t ... mment-formPaul 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
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
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.
and a suggestion: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.
Storm in a very expensive tea cup?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).
phoenix said: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 .
xyzzy said:phoenix said: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 .
Well a few in my use of the English language usually means around 5. So how many people have there been on this forum over the years its been online who have successfully stated they have controlled their T2 by using some form of low carb diet, 100+, 200+ probably even more than that. Starting to be a decent sized sample set wouldn't you say? Surely they are not all making it up or are sock puppet accounts?
To say it's just "a few forum members" belittles the hard work and effort ALL those people put into controlling their condition.
followed by this next statementThere is some speculation among bloggers that the trial was halted because more people died in the intervention group than in the usual care group:
http://high-fat-nutrition.blogspot.co.u ... opped.html
However the massive omission, from the quick look I've managed, is of any intention to report the all cause mortality. It seems very likely to me that more people died in the intervention group than in the usual care group, but p was > 0.05.
Call me a cynic, but I think they stopped the trial because they could see where that p number was heading. Has anyone seen a body count from anywhere in the trial?
This is more excellent evidence against the idiotic (diabetic killing) dietary advice handed out by the NHS and DUK. It demonstrates the inefficacy of both low-calore + exercise and high-carb as a method of treating T2 diabetes
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.
phoenix said:What I object to is the way this topic was introduced : First a statement from a blogger with as far as I know no 'inside knowledge ( A British vet)
There is some speculation among bloggers that the trial was halted because more people died in the intervention group than in the usual care group:
http://high-fat-nutrition.blogspot.co.u ... opped.html
However the massive omission, from the quick look I've managed, is of any intention to report the all cause mortality. It seems very likely to me that more people died in the intervention group than in the usual care group, but p was > 0.05.
Call me a cynic, but I think they stopped the trial because they could see where that p number was heading. Has anyone seen a body count from anywhere in the trial?
phoenix said:Me said:This is more excellent evidence against the idiotic (diabetic killing) dietary advice handed out by the NHS and DUK. It demonstrates the inefficacy of both low-calore + exercise and high-carb as a method of treating T2 diabetes
Sounds scary, people dying.
The National Diabetes Audit 2010-2011 said:Percentage of registered Type 1 patients in England
HbA1c >= 6.5% (48 mmol/mol) = 93.1%
HbA1c > 7.5% (58 mmol/mol) = 71.7%
HbA1c > 10.0% (86 mmol/mol) = 17.5%
Percentage of registered Type 1 patients in Wales
HbA1c >= 6.5% (48 mmol/mol) = 94.9%
HbA1c > 7.5% (58 mmol/mol) = 75.3%
HbA1c > 10.0% (86 mmol/mol) = 20.1%
phoenix said:I don't know of any trials that demonstrate maintenance of a big weight loss over a long time and 11 years is a long time. I wonder how it worked out with individuals. I doubt individual plots would sow a weight loss followed by a slight regain and then a plateau (final 5%) ; some would have lost a lot, some would have yo yoed , some would have gained.
phoenix said:It's no different with 'low carb' Many find it very difficult to maintain their losses. Jimmy Moore was mentioned in another thread linked to this one as a good example of the weight that can be lost on a low carb diet. He's actually a very good example of how difficult it is to maintain weight loss , loosing 170lbs on a low calorie diet, 180lbs on Atkins, 50lbs on his recent venture (and lot's of other big losses in between).
phoenix said:(and sorry for another epic post, I shan't return to this subject ... since I still think it's a storm in a rather expensive teapot)
borofergie said:So we're not allowed to play "n=1" but you're allowed to play "n=Jimmy". If we're going to play "n=Jimmy" let's be accurate about it: the guy has gone from 410lbs in 2003 to 255lb in 2012.
Sorry to disappoint you. My prerogative to change my mind.No, I probably wouldn't if I were you either.
I think that is very much what I have been saying. (certainly what I've been trying to say)Hi Evelyn,
1200 and 1300 are about the same. Jaybird was pretty much 100% in accord with our recommendations.
Thanks for the info about Ebbeling, I basically agree with your posts on Look Ahead. It looks like an ineffective intervention, behavior of the controls was pretty similar to the intervention group, plus they selected unusually healthy diabetics for the trial so they had low event rates and we can’t infer anything from the difference in event rates between study participants and the general population.
Counting calories will probably bring everyone closer to a target, but I doubt it completely suppresses a tendency to eat more calories on a 50% carb diet than on a 30% carb diet. I agree that increased protein intake tends to suppress appetite and calorie intake
phoenix said:Sorry to disappoint you. My prerogative to change my mind.No, I probably wouldn't if I were you either.
I will add that I've just returned to Jaminet's post and looked at the comments. He (unlike you) seems to have moderated his views in his comments and responses to both Guyenet (too much/many to quote) and to Evelyn.
phoenix said:The people on here are a 'few ' people on a forum. Frequent posters are a tiny number of the actual members, they are people who have had a measure of success and find themselves well supported, others though are less supported and unsurprisingly they don't stay. This is not a representative sample. Moreover all have lost weight fairly recently so cannot be compared with what happened over a period of 11 years.
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