Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial

(Sjur GjĆøstein Karevoll) #1

Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial

Quite an interesting study in my opinion. A very-low-calorie diet followed by a period of weight maintenance caused remission of type 2 diabetes in 46% of patients.

The intervention group went on a very-low-calorie diet managed by dietitians or trained nurses while the control group received best practice care by guidelines. The intervention group also discontinued their antidiabetic and antihypertensive medicines at the onset of the study.

The co-primary outcomes were weight loss of 15kg or more and remission of diabetes as defined by HbA1c of less than 6.5%. 34% of the intervention group managed this compared with no patients in the control group. Of the 34% that managed the 15kg weight lost 86% also saw a remission of their diabetes, showing a close association between remission and weight loss.

Along with improved HbA1c the intervention group also saw improvement in triglycerides, insulin sensitivity, visceral fat and blood pressure, possibly also improved insulin secretion.

The diet used in the intervention was 850kcal/day, 59% carbs, 13% fat, 26% protein and 2% fibre.

Is HCG Just Fasting?
(Ken) #2

Of course it worked. Any pattern of caloric restriction below maintenance results in lipolysis/ketosis. This is one of the problems with focusing merely on ketosis, you can still be ketogenic while eating a Carb based diet by restricting calories.

Studies like this are often used to refute a fat based nutritional pattern, feeding the low fat, often anti meat agenda. Of course, once caloric restriction ends, the same adaptive, lipogenic adaptive issues come back and the whole terrible cycle begins again. I did this for decades when I was younger. Itā€™s called yo-yo dieting.

Thatā€™s why the real issue is about Carb based vs fat based nutrition.

(Adam Kirby) #3

850 cals a day will lower your insulin for sure. Unfortunately people will probably take the wrong message and say, see, we should be doing HALF the calories of the Minnesota starvation experiment!

(Randy) #4

Iā€™d just tell them to enjoy their 850 calories a day. Iā€™m going to fry some bacon. :wink:

(Bacon is a many-splendoured thing) #5

I like the way you think! :bacon::bacon:

(Justin Jordan) #6

This is another iteration of the Newcastle study (and indeed, Roy Taylor is one of the authors of this study), studying it over a longer term.

What interesting about the Newcastle results is that when heā€™s talking about remission, he doesnā€™t simply mean normal blood sugar while on the diet. The results were maintained when the subjects returned to an isocaloric, higher calorie diet, so long as they maintained the weight loss.

Which is different than remission of diabetes as usually defined on LCHF, where blood sugars are maintained so long as carbs are low or basically non existent. Which is true for me - Iā€™m a type 2 diabetic, and eating as low a carb diet as I can manage (usually under ten grams, always under twenty) for long periods keeps my blood sugar under control.

For my part, Iā€™d be thrilled to be able to achieve normal blood sugar on 125 grams (which us what is what 59% of 850 calories works out to) let alone a normal blood sugar response.

(Thereā€™s other interesting results in the Newcastle Study - first phase insulin response returns to normal, and the insulin secretion and insulin sensitive in the subjects for whom it worked were all normal. )

(Sjur GjĆøstein Karevoll) #7

While this is true, I doubt itā€™s true on a 120g carb diet, which is what the intervention was. Ketosis is not automatic when youā€™re lipolytic.

The role of macronutrients was not an object of study in this research. Since Iā€™m guessing both groups received very similar macro ratios in their diet thereā€™s nothing that can be said about macros.

In this study the subjects underwent the intervention diet for 3-5 months while the data is reported after 12 months, so they had a period of weight maintenance of 7-9 months depending on how long their individual intervention lasted. The study is also scheduled to last another 4 years of follow-up, so weā€™ll see if things change during that period. However, other studies have shown that most that manage to maintain their weight loss for 12 months manage to more or less maintain it forever.

(Sjur GjĆøstein Karevoll) #8

This was whatā€™s most interesting to me as well. These are people that, after a 3 month intervention, went back to eating a high-carb, high-calorie diet while maintaining their weight for 9 months and still stayed in diabetes remission. Another thing thatā€™s interesting is that even though there was a high association between weight lost and diabetes remission, there were more people who managed the diabetes remission goal than did the weight lost goal, and I would like to see just how that dynamic played out. If some of the subjects lost weight and put their diabetes into remission, then failed to maintain their weight during the maintenance period but still kept their diabetes in remission then that too would be very interesting.

(Clare) #9

This was all over the news in the UK last night. I was actually prepping my dinner with the news on when I heard the intro to the piece - ā€˜Diabetes can be reversed with dietā€™.

Wow I thought - itā€™s not news to me but itā€™s news that itā€™s on the news!

Then I turned to look at the screen and saw the footage of a lady in her fifties chopping up a potato and I thought - uh-oh - whatā€™s this going to beā€¦?

So then I hear it - 800 calories a day in four shakes which taste sweet according to the news presenter who tries one.

So I think - 800 calories a day is going to provide only around 100-ish grams of carbs per day. Maybe 150 at most. Thatā€™s a fair bit more than any of us eat but itā€™s low compared to what most people would be eating in a day.
I remember Gary Taubes saying that a lot of supposedly regular low calorie diets end up being lower carb just because the total amount of food being consumed is so low.

And this was, from my point of view, the worst possible kind of diet to put people on - what are people learning about food from 4 milkshakes a day and to what extent can we expect people to seriously stick to that for several months. Iā€™m always amazed that people think a low carb diet isnā€™t maintainable - we all know that once you get past the early days of it, it becomes pretty easy because everything we get to eat is delicious.

So I think Iā€™d want to know the following -
How many people dropped out of the study?
What support was being given to people once they transitioned back to real food?
And Iā€™d like to see a comparison of the data with people doing a low carb / fasting regimen for the same sort of period.

Iā€™m really happy for anybody that benefitted from this study but I canā€™t help but feel that they could have gotten the same results - or better - without having to torture themselves for months eating nothing but ā€˜milkshakesā€™.

(Sjur GjĆøstein Karevoll) #10

From the commentary article:

Interest to take part in the study was high, and 128 (86%) participants in the intervention group and 147 (99%) participants in the control group attended the 12 month study assessment.

86% retention in the intervention group is pretty high even compared to less severe interventions. The intervention group were guided by dietitians or trained nurses during the intervention. The intervention ended with structured reintroduction of foods leading up to the maintenance phase.

I would be very interesting in a similar study looking at type 2 diabetes remission on a low-carb diet. So far Iā€™ve only seen anecdotal evidence that seems to suggest that while symptoms can be managed and therefore remission as defined by this study can be achieved, insulin sensitivity and secretion doesnā€™t normalize in a similar time-frame to the same degree on a low-carb/fasting regimen. However, since there are no comparable low-carb studies itā€™s impossibly to compare apples to apples yet.

(Richard Hanson) #11

I changed doctors and was prescribed a calorie restricted ketogenic diet of less then 1000 kcal/day. In three months I went from 6 diabetic medications a day, including 75 units of insulin/day, to 0 and an A1C of 9.4% to 6.5%. I was encouraged to include some fasting. Over that time I averaged 888 kcal/day.

I would not have been an eligible participant in the study because I have been T2D for > 15 years instead of < 6 years.

I would have tried this many many years ago if I had any ides at all that diet could cure T2D. Instead, I blindly followed my endocrinologistā€™s advice for over a decade as he blindly followed the ADA standard protocol for treatment. I was continually prescribed more aggressive medication treatments over time.

We can, and should, be critical of flaws in this study, unanswered questions, but the ā€œNEWSā€ is out to the general public, the oblivious public, the ignorant public (including most doctors), that diet can lead to remission of T2D. This is a massive victory for public health. The public needs to hear this message over and over again.

Keto for Life!

Best Regards,
Richard

(Clare) #12

Hey Richard

Youā€™re absolutely right on that.

Like I say - itā€™s not news to us but it is news that itā€™s finally on the news!

:wink:

(bulkbiker) #13

There have never been any long term follow up studies on the ND participantsā€¦ as the first study results were published in 2011 I find this quite interestingā€¦ I have a sneaking suspicion that I know why there havenā€™t been any long term results published but that would make me a conspiracy theoristā€¦

(Justin Jordan) #14

The study referenced in the original post is actually an attempt to see what happens longer term - in this case, twelve months.

Which at a year, the result were pretty consistent with the original study. But the study is meant to go on for several more years.

Taylor actually been applying a genuinely scientific approach to these studies - he followed the original study with a similar one using people whoā€™d had diabetes for longer periods, and then moved into studies with more people, then studies over the longer term.

Which is actually impressive - that kind of rigor is actually pretty sadly lacking in a LOT of studies of nutrition (and exercise, for that matter).

(Justin Jordan) #15

ā€œHow many people dropped out of the study?
What support was being given to people once they transitioned back to real food?ā€

These are actually detailed in the original study papers, if youā€™re interested in looking it up.

(bulkbiker) #16

Possibly true however the studies have to date put fewer than 200 people through the Very Low Calorie Diet under Taylorā€™s auspices with a not great success rate 46% from cherry picked Type 2ā€™s after 12 monthsā€¦ I am a skepticā€¦ especially when you listen to his semi fat shaming eat less move more interview on the Lancet summary of the study. But of course that is just my opinion.

(Justin Jordan) #17

See, to me, 46% of people returned to normal metabolic function is an outstanding success. IF it were just ā€˜returned to normal blood sugarā€™ Iā€™d be whatever - I can do that just by eating a keto diet. But thatā€™s not what the diet did.

But I donā€™t care at all what Taylorā€™s views on fat people are. So thereā€™s that.

(Bacon is a many-splendoured thing) #18

It appears from the abstract, however, that they lost 21 of the participants originally recruited for the intervention group, so weā€™re talking about 58 or so of the original 149. What the abstract doesnā€™t say (and I canā€™t afford a subscription in order to read the full paper), is why the 21 participants withdrew from the study. In fact, the abstract doesnā€™t say that anyone withdrew from the study, but itā€™s a necessary conclusion from the numbers they do put in the abstract. And they have to all have withdrawn from the intervention group, because the same number of control participants is mentioned being evaluated as were originally recruited. So why did 14% of the intervention group fail to last through the study?

(Ken) #19

Of course youā€™ll be ketogenic when eating 120g of carbs. And yes, the substrate is the glycerol once the fat molecule is broken. Ketosis is a part of lipolysis, not the other way around.

Perhaps I missed something, but I though they were following a primarily Carb based diet. A lipogenic, insulin secreting one, but intermittantly dipping into lipolysis once dietary calories run out.

Keeping weight off for a year by following caloric restriction is difficult, but not impossible. One year is really nothing, and eventually leptin resistance begins to rise, beginning the fat gain process.

(Clare) #20

I simply donā€™t currently have time to go through the study at the moment and Iā€™m not 100% sure Iā€™m sufficiently scientifically literate to understand it if I did. Iā€™m an accountant not a doctor.

I will say this - my understanding of the process was that these dieters were given an extraordinary amount of support for the duration of the trial and in then reintroducing foods. Thatā€™s great and itā€™s exactly what we should do for everybody with T2Dā€¦ BUT BUT BUTā€¦

How will this actually be rolled out, if it is rolled out, in general practise?

We all know that there simply arenā€™t sufficient resources to give everybody with T2D this level of personal support. So what will happen is, people will get prescribed these shakes and, for the most part, left to just get on with it then blamed when they fail.

Surely itā€™s better to teach people to eat well and fix themselves that way?