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
Rok vydání: 2018
Předmět:
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