Technical/Professional Information

Aims of DiRECT

• To determine whether a structured weight management programme, delivered in a realistic Primary Care setting, is a viable treatment for producing T2DM remission.

• Extend current knowledge about the mechanisms behind T2DM and its remission

Trial Objectives and Outcome Measures

• Establish whether it is possible to produce remission of T2DM and sustain it over 2 years, similar to the benefits achieved through sustained weight loss after bariatric surgery.

• Elucidate the physiological mechanisms underlying reversal of diabetes

• Quantify quality of life and attitudes during the intervention.

Study Design

Cluster Randomised trial

Who Can Participate?

GP practices across Scotland and Tyneside may enroll in the study. Patients in participating GP practices with T2DM 0-6 years duration, aged 20-65 years, body mass index >27kg/m2, <45kg/m2 and who fulfil all inclusion criteria, will be invited to participate in the study

What does the Study involve?

GP practices will be randomised EITHER to deliver best practice diabetes and obesity management as per clinical guidelines, OR to deliver a low calorie liquid diet using nutritionally complete soups and shakes, followed by structured food reintroduction and long term weight loss maintenance.

A total of 280 participants (140 intervention, 140 control) will be recruited into the study. This means recruiting around 30-35 GP practices. We aim to recruit 5-10 people per GP practice. In each participating GP practice all will receive the intervention to which their practice has been allocated. Tyneside subjects will additionally undergo MR studies of pancreatic and hepatic fat, together with metabolic studies to determine mechanisms underlying T2DM reversal. A random sample of participants and health care professionals will be invited to participate in semi-structured interviews to evaluate programme acceptability, barriers and facilitators to implementation and ease of engagement with the intervention.

All participants will be followed up at 1 and 2 years.

Co-primary endpoints:

• reduction in weight of 15 kg (assumed equal on average to 15%) or more at 1 year

• reversal of diabetes (HbA1c <48mmol/mol) at 1 year

Study Time-Line

• 2 years recruitment –complete Spring/Summer 2016

• 1 year follow up - complete Spring/Summer 2017

• 2 year follow up complete Spring/Summer 2018

• Results available from 2018 onwards