Clinical and metabolic features of the randomised controlled Diabetes Remission Clinical Trial (DiRECT) cohort

• DOI: 10.1007/s00125-017-4503-0
• Publication Date: 2017-11-29T21:32:47Z
• Authors: Roy Taylor; Wilma S. Leslie; Alison C Barnes; Naomi Brosnahan; George Thom; Louise McCombie; Naveed Sattar; Paul Welsh; Carl Peters; Sviatlana Zhyzhne...; Kieren G. Holling...; Ahmad Al-Mrabeh; Angela M. Rodrigues; Lucia Rehackova; Ashley J. Adamson; Falko F. Sniehotta; John C. Mathers; Hazel M. Ross; Yvonne McIlvenna; Sharon Kean; Ian Ford; Alex McConnachie; Michael E. J. Lean
• Keywords: Intention-to-treat analysis

Substantial weight loss in type 2 diabetes can achieve a return to non-diabetic biochemical status, without the need for medication. The Diabetes Remission Clinical Trial (DiRECT), cluster-randomised controlled trial, is testing structured intervention designed and sustain this over years primary care setting determine practicability routine clinical practice. This paper reports characteristics of baseline cohort. People with <6 BMI 27–45 kg/m2 were recruited 49 UK practices, randomised either best-practice alone or an additional evidence-based management programme (Counterweight-Plus). co-primary outcomes, at 12 months, are ≥15 kg remission (HbA1c <48 mmol/mol [6.5%]) glucose-lowering therapy least months. Outcome assessors blinded group assignment. Of 1510 people invited, 423 (28%) accepted; whom, 306 (72%) eligible screening gave informed consent. Seven participants later found have been error one withdrew consent, leaving 298 (176 men, 122 women) who will form intention treat (ITT) population analysis. Mean (SD) age was 54.4 (7.6) years, duration 3.0 (1.7) 34.6 (4.4) all (34.2 (4.2) men 35.3 (4.6) HbA1c (on treatment) 59.3 (12.7) (7.6% [1.2%]). recruitment rate control groups, comparisons between subgroups Scotland England, showed few differences. DiRECT has cohort similar those seen practice, indicating potential widespread applicability. Over 25% wished participate study, including high proportion line prevalence distribution diabetes. www.controlled-trials.com/ISRCTN03267836 ; date registration 20 December 2013