Diabetes Remission Clinical Trial

• Register: ISRCTN
• Last refreshed on: 11 March 2024
• Main ID: ISRCTN03267836
• Date of registration: 20/12/2013
• Prospective Registration: Yes
• Primary sponsor: NHS Greater Glasgow and Clyde (UK)
• Public title: Diabetes Remission Clinical Trial
• Scientific title: Reversal of type 2 diabetes mellitus (T2DM) using non-surgical weight management with Low-Energy-Liquid-Diet and long-term maintenance, within routine NHS care
• Date of first enrolment: 01/01/2014
• Target sample size: 280
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN03267836
• Study type: Interventional
• Study design: Cluster randomized controlled design with GP practices as the unit of randomization (Treatment)
• Phase: Not Applicable

Countries of recruitment

Scotland, United Kingdom

Contacts

• Name: Mike Lean

Key inclusion & exclusion criteria

Inclusion criteria: 1. Men and women aged 20-65 years, all ethnicities
2. T2DM of duration 0-6 years
3. Body Mass Index (BMI) >27 kg/m2
Exclusion criteria: 1. Current insulin use
2. HbA1c =12%
3. Substance abuse
4. Known cancer
5. Myocardial infarction within previous 6 months
6. Learning difficulties
7. Current treatment with anti-obesity drugs
8. Diagnosed eating disorder or purging
9. Pregnant/considering pregnancy
10. Patients who have required hospitalisation for depression or are on antipsychotic drugs

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 diabetes
Nutritional, Metabolic, Endocrine
Type 2 diabetes mellitus

Intervention(s)

Practices randomised to the intervention will deliver Counterweight Plus, which includes a Total Diet Replacement phase followed by structured food reintroduction and long-term weight loss maintenance. Training for the practice nurses/dietitians in TDR delivery, maintenance diet programme and behaviour therapy will be provided by the Counterweight (CW) Specialists, using the training package developed for the Counterweight feasibility study in primary care.

Week 0-12: a commercial micronutrient-replete 825-853 kcal/d TDR (soups and shakes) will be provided to replace normal foods, with ample fluids, for 12 weeks. Participants will be seen for review weekly then every 2 weeks during this phase.
Week 12-18: stepped transition to food-based Weight Maintenance, replacing TDR with meals which contain 30% of energy from fat. During this phase participants will attend for review appointments every 2 weeks.
Weeks 18-104: participants will then be provided with an individually tailored calorie prescription to support weight stabilisation and prevent weight regain with monthly review appointments.

All subjects in the intervention arm who are physically capable will be advised about increasing daily physical activity. As an aid, patients will be recommended to obtain an inexpensive step-counter and to aim to reach and maintain their individual sustainable maximum.

Some patients find weight maintenance difficult, some relapse temporarily and gain weight rapidly. Others may tend to let things slip more gradually. If weight regains occurs in TDR randomised participants, or if diabetes is found to have returned (HbA1c risen above 6.5%) at any time during the 18-month weight loss maintenance stage, ?rescue plans? for weight gain prevention will be offered.

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Primary Outcome(s)

Reduction in weight of 15 kg (assumed equal on average to 15%) or more
Co-primary outcome: Reversal of diabetes (HbA1c <6.5%)
Both outcomes measured at 1 year

Secondary Outcome(s)

1. Quality of life measured by EQ-5D questionnaire
2. Physical activity level measured using Sensewear Monitor
3. Serum lipids
All outcomes measured at 1 year

Secondary ID(s)

GN13DI127

Source(s) of Monetary Support

Diabetes UK (UK), Cambridge Weight Plan (UK) - product and training support

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; West of Scotland Research Ethics Committee 3, 24/01/2014, REC ref: 13/WS/0314

Results

• Results available: Yes
• Date Completed: 30/09/2018