Clinical and metabolic features of the randomised controlled Diabetes Remission Clinical Trial (DiRECT) cohort

Taylor, R. et al. (2018) Clinical and metabolic features of the randomised controlled Diabetes Remission Clinical Trial (DiRECT) cohort. Diabetologia, 61(3), pp. 589-598. (doi:10.1007/s00125-017-4503-0) (PMID:29188339)

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Abstract

Aims/hypothesis: Substantial weight loss in type 2 diabetes can achieve a return to non-diabetic biochemical status, without the need for medication. The Diabetes Remission Clinical Trial (DiRECT), a cluster-randomised controlled trial, is testing a structured intervention designed to achieve and sustain this over 2 years in a primary care setting to determine practicability for routine clinical practice. This paper reports the characteristics of the baseline cohort. Methods: People with type 2 diabetes for <6 years with a BMI of 27–45 kg/m2 were recruited in 49 UK primary care practices, randomised to either best-practice diabetes care alone or with an additional evidence-based weight management programme (Counterweight-Plus). The co-primary outcomes, at 12 months, are weight loss ≥15 kg and diabetes remission (HbA1c <48 mmol/mol [6.5%]) without glucose-lowering therapy for at least 2 months. Outcome assessors are blinded to group assignment. Results: Of 1510 people invited, 423 (28%) accepted; of whom, 306 (72%) were eligible at screening and gave informed consent. Seven participants were later found to have been randomised in error and one withdrew consent, leaving 298 (176 men, 122 women) who will form the intention to treat (ITT) population for analysis. Mean (SD) age was 54.4 (7.6) years, duration of diabetes 3.0 (1.7) years, BMI 34.6 (4.4) kg/m2 for all participants (34.2 (4.2) kg/m2 in men and 35.3 (4.6) kg/m2 in women) and baseline HbA1c (on treatment) 59.3 (12.7) mmol/mol (7.6% [1.2%]). The recruitment rate in the intervention and control groups, and comparisons between the subgroups recruited in Scotland and England, showed few differences. Conclusions/interpretation: DiRECT has recruited a cohort of people with type 2 diabetes with characteristics similar to those seen in routine practice, indicating potential widespread applicability. Over 25% of the eligible population wished to participate in the study, including a high proportion of men, in line with the prevalence distribution of type 2 diabetes. Trial registration: www.controlled-trials.com/ISRCTN03267836; date of registration 20 December 2013

Item Type:Articles
Keywords:Formula diet, remission, type 2 diabetes, weight management.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McConnachie, Dr Alex and Brosnahan, Miss Naomi and Lean, Professor Michael and Welsh, Dr Paul and Kean, Ms Sharon and McIlvenna, Ms Yvonne and Thom, Mr George and Sattar, Professor Naveed and Ford, Professor Ian and Leslie, Dr Wilma
Authors: Taylor, R., Leslie, W. S., Barnes, A. C., Brosnahan, N., Thom, G., McCombie, L., Sattar, N., Welsh, P., Peters, C., Zhyzhneuskaya, S., Hollingsworth, K. G., Al-Mrabeh, A., Rodrigues, A. M., Rehackova, L., Adamson, A. J., Sniehotta, F. F., Mathers, J. C., Ross, H. M., McIlvenna, Y., Kean, S., Ford, I., McConnachie, A., and Lean, M. E.J.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > General Practice and Primary Care
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Diabetologia
Publisher:Springer
ISSN:0012-186X
ISSN (Online):1432-0428
Published Online:30 November 2017
Copyright Holders:Copyright © 2017 The Authors
First Published:First published in Diabetologia 61(3): 589-598
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
614611Reversal of T2DM to normal glucose tolerance using non-surgical weight management with low-energy liquid- diet and long-term maintenance, within routine NHS care: study extensionMichael LeanDiabetes UK (DIABETUK)13/0004691MVLS MED -HUMAN NUTRITION