Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
All participants will follow a Total Diet Replacement (TDR) program providing ~800 kcal/day using commercially available soups and shakes for 8–12 weeks, followed by a 2-week food reintroduction phase
Sponsors
Accord (United Kingdom)
NHS Lothian
Eligibility
Sex/Gender
All
Age
45 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Obese (BMI: 30-45 kg/m²) who have had T2D for less than 6 years or longer than 10 years, and are on treatment with diet alone or diet plus oral medication 2. Obese (BMI: 30-45 kg/m²) who are at the pre-diabetes stage, defined as fasting blood glucose 5.6-6.9 mmol/L 3. Obese (BMI: 30-45 kg/m²) who are non-diabetic (control group) 4. Age between 45 and 79 years inclusive 5. Men and women, however, post-menopausal women only (to exclude sex hormone effects on lipid metabolism) 6. Good communication in English (able to give informed consent and follow dietary advice) 7. Willing and able to adhere to the study protocol, including dietary intervention and scheduled follow-up visits
Exclusion criteria
Exclusion criteria: 1. Insulin therapy 2. HbA1c >12% (108 mmol/mol) 3. Weight loss >5 kg in the last 6 months 4. Recent MI (within 6 months) 5. Known cancer in the last 5 years 6. First-degree relatives of people with T2D (control group) 7. History of gestational diabetes 8. MRI contraindications (metal implants, claustrophobia) 9. Alcohol >14 units/week 10. Advanced kidney or liver disease 11. Use of steroids or antipsychotics 12. Participation in another clinical trial 13. Life expectancy <1 year 14. Allergy to local anaesthetic (for biopsy subgroup) 15. Any disorder that may jeopardise safety or compliance
Countries
Scotland, United Kingdom
Contacts
Public ContactMary Wright
Outcome results
None listed