DIADEM-I expands DiRECT approach to Middle East
medwireNews: The DIADEM-I randomized trial demonstrates substantial remission of type 2 diabetes in people from the Middle East and in north Africa after they undertake a total meal-replacement very-low-calorie diet.
The study builds on the success of the DiRECT trial, which demonstrated type 2 diabetes remission in primary care after weight loss achieved through 3 months of a very-low-calorie, total meal-replacement diet. But DiRECT was a UK study and therefore involved mostly White participants.
In a commentary on the current study in The Lancet Diabetes & Endocrinology, DiRECT investigator Roy Taylor (Newcastle University, UK) says: “The degree of fat deposition in the liver and pancreas is known to be typically lower in people of black African ethnicity, and whether type 2 diabetes in other ethnic groups shares the same pathogenesis and would respond to weight loss in the same way has been questioned.
“Additionally, attitudes to weight loss and food are affected by cultural factors, and willingness to achieve weight loss cannot be assumed.”
The DIADEM-I investigators, led by Shahrad Taheri (Weill Cornell Medicine Qatar, Doha), report that 61% of their study participants given the intervention achieved type 2 diabetes remission at 12 months. This is a higher remission rate than the 46% achieved in DiRECT, which Taylor observes “is consistent with the shorter duration of diabetes and possibly the younger age of participants in the DIADEM-I study.”
DIADEM-I involved 158 participants, who were an average age of 42.1 years and had an average BMI of 34.9 kg/m2. Their average diabetes duration was 21.2 months and glycated hemoglobin was 7.0% (53 mmol/mol).
Similar to the DiRECT study, the 77 participants in the active treatment group undertook 12 weeks of a total meal-replacement diet providing approximately 800 kcal/day, followed by a phased reintroduction of normal food. This resulted in an average weight loss of 11.98 kg by 12 months, with 60%, 34%, and 21% of participants losing more than 5%, 10%, and 15%, respectively, of their bodyweight.
By comparison, average weight loss was 3.98 kg for the 70 participants of the control group, who received usual care, with a corresponding 29%, 9%, and 1% achieving the three weight loss thresholds. Nine (12%) of these people achieved diabetes remission.
In contrast with DiRECT, the DIADEM-I participants assigned to the diet group were given a wrist-worn accelerometer and encouraged to increase their physical activity, which Taylor notes can result in compensatory eating. Although they reported a significant reduction in sedentary time and corresponding increase in walking time, there was no change in moderate-to-vigorous activity and no overall difference for metabolic equivalent of task minutes per week.
“The DIADEM-I study firmly establishes the feasibility of achieving dietary remission of type 2 diabetes in populations in which the disease is so prevalent and economically damaging,” concludes Taylor in his commentary.
But he notes that around half of the DiRECT participants required reintroduction of the total meal-replacement plan to combat weight gain during longer-term follow-up; the rate of diabetes remission fell to 36% at 2 years.
He concludes: “The number one question is now clear: what is the best strategy to avoid weight regain and maintain remission of type 2 diabetes?”
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