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The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial
Open accessAbstract
BACKGROUND: Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33% of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. METHODS/DESIGN: Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65 years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m(2). Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. DISCUSSION: This study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03267836 . Date of Registration 20/12/2013.
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“as both excess weight and higher glucose exert their effects through aggregated exposure. 15,16”
From 5-year follow-up of the randomised Diabetes Remission Clinical Trial (DiRECT) of continued support for weight loss maintenance in the UK: an extension study (2024) · cites this paper as [16]
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“Bariatric surgery has dominated discussions of type 2 diabetes remission as the most effective way of producing major weight loss.8,9,10”
From Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial (2018) · cites this paper as [10]
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“the overall loss to follow up of 14·1% over 2 years is modest for a weight loss study in real-life conditions. 14”
From 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 (2019) · cites this paper as [14]
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Metadata
- Authors
- Leslie, W. S., Ford, I., Sattar, N., Hollingsworth, K. G., Adamson, A., Sniehotta, F. F., McCombie, L., Brosnahan, N., Ross, H., Mathers, J. C., Peters, C., Thom, G., Barnes, A., Kean, S., McIlvenna, Y., Rodrigues, A., Rehackova, L., Zhyzhneuskaya, S., Taylor, R., & Lean, M. E. J.
- Affiliations
- University of Glasgow (GB)
- Newcastle University (GB)
- Corresponding author
- Leslie, Wilma S.
- ORCID
- Venue
- BMC Family Practice
- Published
- 2016-02-16
- Volume
- 17
- Issue
- 1
- Pages
- 20-20
- ISSN
- 1471-2296 (ISSN-L)
- PMC
- PMC4754868
- OpenAlex
- W2282195952
- Semantic Scholar
- 0f0410d96cb805bf52b3e656880025aa434012bb
- Cited by
- 132
- References
- 28
- Citations by year
- 2026: 9 · 2025: 10 · 2024: 14 · 2023: 8 · 2022: 12 · 2021: 30 · 2020: 11 · 2019: 14 · 2018: 10 · 2017: 12 · 2016: 1
- FWCI
- 12.39
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Family Practice (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Northumbria Research Link (Northumbria University) (acceptedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- Newcastle University ePrints (Newcastle Univesity) (cc-by)
- Funders
- Diabetes UK (13/0004691)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes remission, weight management, hypocaloric diet, primary care, normoglycemia, HbA1c, pancreatic fat, liver fat, insulin secretion, obesity, weight loss maintenance
- MeSH terms
- Adult, Aged, Diabetes Mellitus, Type 2, Diet, Reducing, England, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Obesity, Primary Health Care, Remission Induction, Scotland, Young Adult, Weight Reduction Programs
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