Question: Multiple trials have shown short-term reversal of diabetes through diet and/or exercise. Are these reversals durable?
Takeaway: The results of the DiRECT trial, and others like it, indicate durable diabetes reversal without medication or surgery is possible. The diabetes community is beginning to shift away from viewing the condition as chronic and progressive and toward understanding it as treatable.
This short, March 2019 commentary, published alongside the two-year results of the DiRECT trial (1), argues there is now sufficient evidence to target diabetes treatment (i.e., reversal), not just symptom management, within the general population.
The DiRECT trial placed 149 diabetic adults on a “total replacement” diet for 3-5 months until specific weight loss targets were achieved (2). All food was replaced with 825-853 calories per day in meal replacement shakes, supplements, and other artificial food sources — all designed to minimize caloric intake while preventing nutrient deficiencies.
All subjects discontinued medication at the beginning of the intervention (3). At one year, 46% of subjects had achieved diabetes remission, defined as an HbA1c < 6.0% (4). At two years, 36% of subjects maintained remission. Only 3% and 4% of control subjects achieved remission at one and two years, respectively.
The authors note the likelihood of diabetes remission increased with greater weight loss and argue weight loss is the driver of remission. This conclusion is not necessarily true, however, as a third factor (e.g., improvements in organ-specific or whole-body insulin resistance) may directly cause both these visible, clinical improvements.
The DiRECT trial, this commentary notes, would be difficult to scale. Patients were offered 30 minutes each month with a dietitian or clinician for the entire two-year trial. The average U.K. resident sees a primary care nurse for 12.8 minutes each year (5); thus, the DiRECT approach would require a substantial increase in available nurse and dietitian time. One in 12 adults worldwide is currently diabetic (6). Reaching this enormous population will require interventions that are effective, simple, and straightforward (i.e., they would need to support consistent adherence with minimal education and oversight), or that can be delivered and overseen by individuals outside the traditional medical infrastructure.
This commentary indicates there is a specific opportunity for community-based diet and lifestyle interventions with demonstrated effectiveness to reverse diabetes at scale. As the diabetes community continues to recognize diabetes is in fact a reversible disease and not necessarily a chronic, progressive condition, these interventions may have an opportunity to play an increasingly prominent role in diabetes prevention and treatment.
Notes
- Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial
- Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label,cluster-randomized trial
- This is common in trials of highly restrictive diets, as maintaining medication alongside severe calorie or carbohydrate restriction can lead to hypoglycemia.
- How do we define cure of diabetes?
- Clinical workload in UK Primary care: A retrospective analysis of 100 million consultations in England, 2007 – 2014
- World Health Organization: Global Report on Diabetes
Comments on Type 2 Diabetes: Treating Not Managing
Well at least the Lancet community is looking for a non drug alternative to actually reversing and preventing type 2 diabetes but calorie restriction is almost a sure fire way to fail in the long run. They could have gotten dramatic results by getting people off sugar and carbs in about 30 days. I have to wonder if they even wanted to reverse the illness.. Weight loss is not the driving factor in type 2 diabetes reversal. The elephant in the room that nobody wants to discuss is sugar. You want the truth ?? Follow the money trail. The solution is so simple. Get off the couch and off the carbs NO SUGAR... It's a drug for goodness sake. And although the food manufactures and COKE are partially to blame the ultimate responsibility falls to the individual. It is not the governments job to keep us healthy.
A few quotes from the commentary I found interesting.
“The findings from DiRECT strongly suggest that the key to diabetes remission is weight loss. The investigators tested a rapid weight-loss regimen, aiming to achieve an initial 15 kg weight loss, which they regarded as a threshold at which remission was more likely. However, the trial results suggest a linear relation: the greater the weight loss, the greater the chance of remission, with no apparent threshold.”
I like what was written in the summary, that the weight loss might be a result of better insulin management, not the other way around. JR made a great point that any reduction in calories also implies a reduction in carbohydrates.
“Multiple visits bring substantial additional costs to the health system, patients, and the wider economy (since such appointments will often require time off work). Irrespective of cost- effectiveness, providing this programme at scale would challenge primary care provision worldwide. For example, in the UK, people see a primary care nurse for 1·28 10-min appointments per year on average.12 If 25% of people with type 2 diabetes were to follow the DiRECT programme, this would necessitate a roughly 50% increase in total nurse consultation time and therefore workforce.”
Let me put on my green eyeshade for a moment and play accountant. Yes, there would be an increased cost to offer nutrition counseling to people. Especially at the onset. I suspect this cost would be offset over time by the reduced cost of medications and treatments for diabetes complications. Of course, people might live longer and collect more social security checks...but that's not really a problem for public health.
And how sad is that the average person gets 12 minutes of attention per year from a doctor?
“…about half of the intervention participants resumed their total diet replacement on at least one occasion, but even so, there was a mean of 2·6 kg weight regain between the 12-month and 24-month assessments, so further evidence is needed.”
Pretty typical of most calorie reduction diets. What I would love to see in the future is a head-to-head competition between Virta, DIRECT, Jason Fung's IDM and see whose program wins. It would be nice if the free market could pick the winner, but healthcare is about as far as you can get from a free market.
My library does not get this journal. I would be grateful for a copy. The question I would search is the extent to which the authors compare those results to those of Hallberg, et al. which appear to be better and require a far less demanding intervention.
I did once compare, superficially, Virta vs. DiRECT. There is a draft available for 2 years at https://www.directclinicaltrial.org.uk/Publications.html
Virta had worse patients with longer duration of t2d than Direct. Virta did not exclude insulin injectors, Direct may have done so. Virta had better outcomes in each and every measurement.
Putting these two together, they are successes both. Usual care was useless in both. As usual.
Direct has this obsession into "weight loss" and "balanced" nutrition. They miss the point that 50% of 800kcal is 100g of carbs. Without realising, they apply low carb diet. Below, they acknowledge Virta (30) but negate it the following sentence (31). Not randomised vs meta-(r)ct? The latter I wish not to open, reminds me of Naude &all "fraud/stupidity" in Noakes trial.
"A recent study of people with type 2 diabetes has demonstrated
substantial weight loss, reduced glycaemia and decreased medications with a very low carbohydrate
diet, although this was not randomised .30
However, meta-analyses of the controlled trial evidence
show no important differences between high and low carbohydrate diets for weight control or
HbA1c .31"
JR
Type 2 Diabetes: Treating Not Managing
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