Intensive life-style intervention, including initial weight-loss with TDR, delivered 60% diabetes remission in people with early type 2 diabetes mellitus from the Middle East and North Africa studied in Qatar
Posted On: 22nd May 2020
The DiRECT trial of weight loss in obese people with early type 2 diabetes with TDR followed by food reintroduction then a structured weight maintenance programme has established beyond reasonable doubt that the weight changes and diabetes remission can be sustained in a proportion of participants for two years. Mechanisms of the effect are beginning to be understood with reduction of inflammation as well as blood pressure and insulin resistance, but thus far all work has been done on European populations. Obesity, diabetes and other comorbidities affect middle eastern populations to a greater extent than the people of Europe and this paper fills the gap for hard evidence in this non-European population.
Professor Taheri and his colleagues at the Weill Cornell Medicine Qatar, studied 147 eighteen to 50 year old participants with early diabetes (3 years or less since diagnosis and 73% were men) in a primary care and community setting, 70 receiving the intervention programme starting with a 12 week Total Diet Replacement (TDR) programme providing just over 800kcal per day in four nutritionally complete formula food products followed by gradual food reintroduction and weight maintenance. There was a strong element of behavioural therapy (focussing on self-monitoring, goal setting, stimulus control, planning, etc) provided by dietitians and physical activity support from sports trainers. The control group followed usual best practice with usual medical management of risk factors and diabetes education and support.
The average greatest weight loss from an average baseline of 101kg in the intervention group occurred at 6 months but the sustained weight loss at 12 months was just under 12kg whereas in the control group it was just a little under 4kg. Diabetes remission at 12 months was 61% in the intervention group with about half of those having normal blood glucose levels and half having ‘pre-diabetic’ levels, compared to 12% remission in the control group (4% with normal blood glucose levels).
Physical activity monitoring showed 40 minutes/day less sedentary time in the intervention group, compared to 69 minutes more in the control group, while a measure of walking equivalence increased by 21 minutes daily in the intervention group and decreased 33 minutes in the control group. There was a 90% and 40% reduction of anti-diabetes and antihypertensive medication use respectively in the intervention group, contrasting with an 11% and 37% increase of anti-diabetes and antihypertensive medication use respectively in the control group.
Commenting on the results Professor Anthony Leeds, Chairman of TDMR Europe said “This paper confirms that diabetes remission after weight loss with TDR followed by a strong maintenance programme is possible in a high proportion of participants with type 2 diabetes from the Middle East and North Africa. The weight losses and metabolic changes were consistent with findings from the DiRECT and DROPLET studies. This is a landmark study on a population that has not previously been studied and as such it has enormous significance for the whole of the Middle East and North Africa. The key to this success is the combination of a large weight loss with TDR, intense behavioural therapy guidance and a structured physical activity programme provided by a team of dietitians, sports trainers and doctors.”
Referring to next steps Prof Leeds said that he hoped WHO and health departments in Middle Eastern and North African countries would take note of these results and consider ‘rolling-out’ the intervention as is being done in the UK by NHS England and NHS Scotland. He added ‘European countries with north African and Middle Eastern communities can now consider this approach to diabetes remission for these high-risk groups.’
Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial. Taheri S etal Lancet Diabetes Endocrinol 2020;8: 477-489 DOI: https://doi.org/10.1016/S2213-8587(20)30117-0
The protocol is described at: Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial. Taheri S et al. Trials 2018; 19:284 https://doi.org/10.1186/s13063-018-2660-1
The study was funded by the Qatar National Research Fund and used Cambridge Weight Plan TDR products.