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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
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:  http://isrctn.com/ISRCTN03267836
Study type:  Interventional
Study design:  Cluster randomised controlled design with GP practices as the unit of randomisation (Treatment)  
Phase:  Not Applicable
Countries of recruitment
United Kingdom
Contacts
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Name: Mike  Lean
Address:  Professor of Human Nutrition University of Glasgow 4th Floor Walton Building Glasgow Royal Infirmary 84 Castle St G4 0SF Glasgow United Kingdom
Telephone: -
Email: Mike.Lean@glasgow.ac.uk
Affiliation: 
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.

Tyneside patients will be invited to participate in studies to define the physiological mechanisms underlying the long-term reversal of T2DM. These participants will have magnetic resonance measurements of pancreas and
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)
Changes in:
1. Quality of life measured by EQ-5D questionnaire
2. Physical activity level measured using Sensewear Monitor
3. Serum lipids, all at one year
Secondary ID(s)
GN13DI127
Source(s) of Monetary Support
Diabetes UK (UK), Cambridge Weight Plan (UK) - product and training support
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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