Diabetes 

Recruitment status:

Recruiting

Primary Sponsor:

NHS Greater Glasgow and Clyde (UK)

Recruitment countries:

United Kingdom

Health condition studied:

Type 2 Diabetes
Nutritional, Metabolic, Endocrine

URL:

Link to the clinical trial website

About the trial

Interventions:

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

Key inclusion and 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

Primary outcomes:

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 outcomes:

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

Target sample size:

280

Study type:

Interventional

Study design:

Cluster randomised controlled design with GP practices as the unit of randomisation (Treatment)

Contacts:

• Name:
• Address:
• Phone:
• Email:
• Affiliation:

• Name: Mike Lean
• Address: Professor of Human Nutrition University of Glasgow 4th Floor Walton Building Glasgow Royal Infirmary 84 Castle St
• Phone: -
• Email: Mike.Lean@glasgow.ac.uk
• Affiliation:

Technical details

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

Sources of monetary support:

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

Secondary sponsors:

Main ID:

ISRCTN03267836

Secondary ID:

GN13DI127

Register:

ISRCTN

Date of registration:

20/12/2024

Date of first enrollment:

01/01/2025

Last refreshed:

13 January 2025