Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial
Autor: | Yvonne McIlvenna, Ashley J. Adamson, Paul Welsh, Renae J. Stefanetti, Ahmad Al-Mrabeh, Naveed Sattar, H. M. Ross, Wilma S Leslie, Lucia Rehackova, Sviatlana Zhyzhneuskaya, Kieren G. Hollingsworth, Carl Peters, Roy Taylor, Michael I. Trenell, Sharon Kean, George Thom, Ian Ford, Angela M. Rodrigues, John C. Mathers, Louise McCombie, Alison C. Barnes, Michael E. J. Lean, Alex McConnachie, Falko F. Sniehotta, Naomi Brosnahan |
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Rok vydání: | 2018 |
Předmět: |
education.field_of_study
Pediatrics medicine.medical_specialty business.industry Population 030209 endocrinology & metabolism General Medicine Type 2 diabetes medicine.disease Disease cluster law.invention B900 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law Weight loss Diabetes mellitus Weight management medicine 030212 general & internal medicine medicine.symptom education business |
Zdroj: | The Lancet. 391:541-551 |
ISSN: | 0140-6736 |
Popis: | Background: \ud Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes.\ud \ud Methods: \ud We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20–65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27–45 kg/m2, and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825–853 kcal/day formula diet for 3–5 months), stepped food reintroduction (2–8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% ( |
Databáze: | OpenAIRE |
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