‘TDR to achieve diabetes remission and diabetes risk reduction’ – Mike Lean

Posted On: 4th August 2020

Mike Lean, University of Glasgow

Type 2 diabetes (T2D) affects nearly 4 million UK people, previously considered permanent and inevitably progressive, with disabling, life-shortening complications.  It accounts for ~10% of total healthcare expenditure across Europe.  It is caused by adult weight gain in people with family/genetic predispositions.  The Diabetes Remission Clinical Trial (DiRECT) has radically changed perceptions of T2D, and changed routine diabetes care.

DiRECT validated a structured primary-care weight management approach using 12-weeks 830kcal/day formula Total Diet Replacement (Counterweight-Plus), and then structured low-intensity support for long-term weight/remission maintenance. The programme, using current TDR formulation, proved well-accepted, entirely safe, and highly effective.  Almost half of all patients were no longer diabetic at 12-months (off all medications, HbA1c<48mmol/mol), and with >10 kg loss 75% remained in remission at 2 years, plus lower blood pressures with fewer antihypertensive medications. Remissions were directly related to loss of damaging ‘ectopic’ fat in liver and pancreas. Serious Adverse Events were significantly more frequent in the Control (usual care) group: the intervention protected against vascular complications of T2D.  Cost-effectiveness analysis projected longer survival, better quality-of-life, and lower lifetime medical costs.

Remission, using the DiRECT approach, is now a primary treatment target in European (EASD) and ADA guidelines. The most expensive component, potentially limiting use, is the TDR formula.

Any requirement to change the composition of the TDR used in DiRECT would need to be justified with evidence for better outcomes and acceptablility, without adding cost.  There is no evidence that higher protein contents would improve outcomes: that would increase costs and reduce palatability. Magnesium content is not too high: diarrhoea was infrequent, and reducing magnesium would likely aggravate constipation on TDR.  Choline is not an essential micronutrient in adults, not required in the diet


Mike Lean TDMR

Professor Mike Lean has held the Rank Chair of Human Nutrition since 1992. He is also head of the department of Human Nutrition. He trained in medicine at the University of Cambridge and St Bartholomew’s Hospital subsequently specialising in general medicine, diabetes and endocrinology.

Total Diet & Meal Replacements Europe (TDMR Europe)’s webinar, ‘Reducing future risk: Obesity co-morbidities and nutritional status’, attracted over 100 academics, policymakers and medical specialists from all over the world.

The webinar, which had been awarded SCOPE World Obesity Federation accreditation, highlighted the use of total diet replacements to reduce future risk of diabetes and cardiovascular disease and diminish severe outcomes in COVID-19 among at-risk subgroups within populations. The speakers discussed a range of diverse and challenging topics, including obesity, nutritional status and COVID-19, TDR to achieve diabetes remission and diabetes risk reduction, TDR and vitamin D status in elderly obese people with knee osteoarthritis, and research needs and translation into practice in the context of diabetes remission.

TDMR Europe represents the voice of European manufacturers and distributors of formula diet products, including Total Diet Replacements (TDRs) and Meal Replacement Products (MRPs), that provide weight loss and weight management programmes for overweight and obese individuals.

If you would like to contact TDMR Europe to discuss the webinar or any other matter, email secretariat@tdmr-europe.com.

1.Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1.
  1. Lean ME, Leslie WS, Barnes AC, et al. 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. Lancet Diabetes Endocrinol 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3.
  2. Lean ME, Low-calorie diets in the management of type 2 diabetes mellitus. Nat Rev Endocrinol 2019 May;15(5):251-252. doi: 10.1038/s41574-019-0186-6.