چکیده (انگلیسی):

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 asthe unit of randomisation: 280 participants
from around 30 practices in Scotland and England will be allocated eitherto 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 20-65years, 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