Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes
Conditions
Interventions
The study follows a randomised controlled design. A blinded envelope system is used for treatment allocation. Participants randomised to control group continue with usual care for three months before
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria 2. Written informed consent 3. Men and women aged 18-65 years 4. South Asian ethnicities 5. Body mass index (BMI)>25 kg/m2 and 48 mmol/mol and/or fasting plasma glucose > 7 mmol/l within last 12 months
Exclusion criteria
Exclusion criteria: 1. Current insulin use 2. Recent routine HbA1c on record =12% 3. Weight loss of >5kg within the last 6 months 4. Recent eGFR on record <30 mls/min/1.732 5. Substance abuse 6. Known cancer 7. Myocardial infarction within previous 6 months 8. Severe or unstable Heart Failure defined as equivalent to the New York Heart Association (NYHA): Grade 3 - marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or breathlessness, and Grade 4 - unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. or Grade 2 if symptoms are not attributed to obesity - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or breathlessness 9. Learning difficulties 10. Not fluent in English language 11. Current treatment with anti-obesity drugs 12. Diagnosed eating disorder or purging 13. Pregnant 14. Patients who have required hospitalisation for depression or are on antipsychotic drugs 15. People currently participating in another clinical research trial 16. People with metal implants or devices and those who have claustrophobia cannot take part as MR scans are required as part of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number recruited to the study: analysis of trial data, at close of recruitment period, on number consented into study 2. Weight loss achieved, and changes in diabetes status: measurement of body weight and HbA1c at baseline, end of total diet replacement phase, and completion of intervention 3. Programme retention: analysis of trial data, at close of study, on number of participants completing the intervention 4. Acceptability of the intervention to people of South Asian origin measured using a process evaluation questionnaire on completion of intervention 5. Definition of the mechanisms behind type 2 diabetes remission in the South Asian population is measured using MRI scanning at baseline and point of maximal weight loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life is measured using the EQ-5D-3L questionnaire at baseline and end of intervention | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactWilma Leslie
Outcome results
None listed