The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial

Area of Science:

• Endocrinology
• Metabolic Diseases
• Public Health

Background:

• Type 2 diabetes (T2DM) causes significant vascular complications and mortality.
• Biochemical remission of T2DM is achievable with substantial weight loss (>15kg) via bariatric surgery or non-surgical interventions.
• The Counterweight-Plus program demonstrates >15kg weight loss in 33% of patients managed in primary care.

Purpose of the Study:

• To determine if a structured, intensive weight management program delivered in primary care can achieve durable Type 2 diabetes remission.
• To investigate the mechanistic basis of T2DM remission.
• To identify psychological predictors of treatment response.

Main Methods:

• Cluster-randomised trial with GP practices as the unit of randomisation.
• 280 participants (T2DM duration 0-6 years, BMI 27-45 kg/m²) allocated to usual care or Counterweight-Plus program.
• Counterweight-Plus involves 12-20 weeks low-calorie diet, food reintroduction, and maintenance; includes MR and metabolic studies for mechanistic insights.

Main Results:

• Co-primary endpoints: weight reduction ≥15 kg and HbA1c <48 mmol/mol at one year.
• Further follow-up at 2 years to assess durability of remission.
• Analysis of pancreatic and hepatic fat, and metabolic markers to understand remission mechanisms.

Conclusions:

• This study will establish the viability of a structured weight management program delivered in primary care for achieving T2DM remission.
• Results will inform future strategies for T2DM management and service delivery.
• Findings expected from 2018 onwards.