Evidence map›Paper›PMID 41877322›Full record

Trial reportBMJ open2026

Combining structured exercise with a low-energy diet to attenuate lean mass loss in South Asian adults living with type 2 diabetes: the COMBINE randomised trial protocol.

Franciskos Arsenyadis, Joseph Henson, Matthew McCarthy, Dimitris Papamargaritis, James A King, Emma Redman, Gráinne Whelehan, Thomas Wilkinson, Jack Sargeant, Alex Rowlands and 7 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Franciskos ArsenyadisUniversity of Leicester Diabetes Research Centre, Leicester, UK fa280@leicester.ac.uk.ORCID http://orcid.org/0000-0003-3885-0548
Joseph HensonDiabetes Research Centre, NIHR Leicester Biomedical Research Centre, Leicester, UK.
Matthew McCarthyUniversity of Leicester Diabetes Research Centre, Leicester, UK.
Dimitris PapamargaritisUniversity of Leicester Diabetes Research Centre, Leicester, UK.
James A KingNIHR Leicester Biomedical Research Centre, Leicester, UK.
Emma RedmanUniversity of Leicester Diabetes Research Centre, Leicester, UK.
Gráinne WhelehanNIHR Leicester Biomedical Research Centre, Leicester, UK.
Thomas WilkinsonUniversity of Leicester Diabetes Research Centre, Leicester, UK.
Jack SargeantUniversity of Leicester Diabetes Research Centre, Leicester, UK.
Alex RowlandsUniversity of Leicester Diabetes Research Centre, Leicester, UK.
Normand BouléFaculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, Alberta, Canada.
Kaberi DasguptaDivisions of Clinical Epidemiology and Internal Medicine, McGill University Health Centre, Montreal, Québec, Canada.ORCID http://orcid.org/0000-0002-2447-3553
Gerry P McCannNIHR Leicester Biomedical Research Centre, Leicester, UK.ORCID http://orcid.org/0000-0002-5542-8448
Melanie J DaviesNIHR Leicester Biomedical Research Centre, Leicester, UK.
Kamlesh KhuntiUniversity of Leicester Diabetes Research Centre, Leicester, UK.
Pratik ChoudharyUniversity of Leicester Diabetes Research Centre, Leicester, UK.
Thomas YatesUniversity of Leicester Diabetes Research Centre, Leicester, UK.

Funding

Wellcome Trust
6 · The paper itself

Abstract

introductionThe global prevalence of type 2 diabetes (T2D) is rising and disproportionately affects South Asian adults, including those in the United Kingdom. South Asians develop T2D at a higher rate and at a younger age than their white British counterparts, at a lower body mass index. Active efforts to reduce adiposity can improve glycaemic control and in some cases achieve T2D remission. However, a substantial proportion of lean mass is lost while achieving weight loss, which may have physiological and metabolic consequences, affecting long-term health outcomes and quality of life for people living with T2D and obesity. We are examining the impact of a combined low energy diet and supervised exercise intervention versus a low energy diet alone for the preservation of lean mass in an understudied South Asian population living with T2D and excess adiposity. METHODS AND ANALYSIS: This prospective, randomised, two-arm parallel-group, open-label, blinded-endpoint trial is being conducted in Leicester, UK. 36 South Asian adults aged 40-65 years within 10 years of T2D diagnosis and not on insulin therapy will be enrolled. Both intervention arms will receive an 800-900 kcal/day low energy diet for 12 weeks. Those randomised to the exercise group will additionally receive a mixture of supervised and home-based resistance and aerobic exercise training three times per week. The primary outcome is the difference in the change of lean mass between groups measured using dual-energy X-ray absorptiometry at baseline and 12 weeks and will be analysed using linear regression modelling. ETHICS AND DISSEMINATION: The trial was approved by the NHS research ethics service (23/WM/0201). All participants will provide informed consent prior to enrolment, and the study will be conducted in accordance with the Declaration of Helsinki. Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial. TRIAL REGISTRATION NUMBER: ISRCTN11175684.

Indexed as

Caloric RestrictionDiabetes Mellitus, Type 2Diet, ReducingExerciseExercise TherapyAdiposityAdultAgedAsia, SouthernBody Mass IndexFemaleHumansMaleMiddle AgedObesityProspective StudiesDiabetes Mellitus, Type 2ExerciseNUTRITION & DIETETICSObesity

Identifiers

PMID41877322
PMCPMC13034260

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.