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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

Lookup NU author(s): Alison Barnes, Dr Carl Peters, Dr Sviatlana Zhyzhneuskaya, Dr Ahmad Al-Mrabeh, Dr Kieren Hollingsworth, Dr Angela Rodrigues, Dr Lucia Rehackova, Professor Ashley Adamson, Professor Falko Sniehotta, Professor John Mathers, Professor Roy Taylor

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


Abstract

Background: DiRECT reported diabetes remission at one year for 46% of participants allocated to an integrated structured weight management programme. We now assess two-year findings. Methods: DiRECT is an open-label, cluster-randomised, controlled trial in primary care practices randomised to a weight management programme (intervention) or best-practice care by guidelines (control). We recruited individuals aged 20–65 years, with <6 years duration of type 2 diabetes, body-mass index 27–45 kg/m2, and not receiving insulin. The intervention comprised withdrawal of anti-diabetes and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet) for 12-20 weeks, stepped food reintroduction (2–8 weeks), and then structured support for weight loss maintenance. Co-primary outcomes, analysed hierarchically, were weight loss >15 kg, and remission of diabetes, defined as HbA1c <6·5% (<48 mmol/mol) with no anti-diabetes medications. Findings: At 24 months, 53/149 (35·6%) of those commencing the intervention and 5/149 (3·4%) in the control group (adjusted odds ratio 25·8, 95% CI 8·3,80·8; p<0·0001) had remission, and 11·4% of intervention and 2·0% of the control group (adjusted odds ratio 8·2 (2·2,30·0), p=0·0015) had weight loss ≥15kg. Of those maintaining ≥10kg weight loss (45/272), 64% (29/45) achieved remission, and 24.2% (36/149) of the intervention group maintained ≥10kg weight loss. Adjusted mean differences between groups were, in changes in body weight -5·4 kg, (-6·9,-4·0), p<0·0001, in HbA1c -4·8 mmol/mol, (-8·3,-1·4), p=0·0063 despite >50% fewer anti-diabetes agent use in intervention group, and SBP -3·4 mmHg, (-6·7,-0·2), p=0·0397. Serious adverse events were similar at 12 months, but fewer occurred in intervention than control in the second year (9 vs. 22). Quality of life improved more from baseline in the intervention than the control group, adjusted mean difference 4·6 (0·4,8·9, p=0·032). Interpretation: This programme sustained remissions at 24 months for over a third of people with type 2 diabetes. Weight loss of ≥10 kg provides remission for two thirds. Funding: Diabetes UK.


Publication metadata

Author(s): Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabehm A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R

Publication type: Article

Publication status: Published

Journal: Lancet Diabetes & Endocrinology

Year: 2019

Volume: 7

Issue: 5

Pages: 344-355

Print publication date: 01/05/2019

Online publication date: 06/03/2019

Acceptance date: 13/02/2019

Date deposited: 23/02/2019

ISSN (print): 2213-8587

ISSN (electronic): 2213-8595

Publisher: The Lancet Publishing Group

URL: https://doi.org/10.1016/S2213-8587(19)30068-3

DOI: 10.1016/S2213-8587(19)30068-3


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