Specialty: Diabetes, Primary sub-specialty: Both
Conditions
Interventions
Participants will be randomised to one of four treatment groups on a 1:1:1:1 format with stratification by age [1.=50years 2.>50years] and Body Mass Indices (BMI) [1. BMI 25.0-29.9kg/m2 2. BMI =30.0k
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and postmenopausal female participants aged between 30-70 years of age inclusive 2. Type 2 diabetes on diet and lifestyle control or stable dose of metformin only for at least 3 months 3. Stable weight (less than 5% change in body weight in last 3 months) – determined by self-reporting or documentation in clinical records 4. HbA1c 48-86mmol/mol (6.5 - 10%) 5. eGFR=60ml/min/1.73m2 6. BMI = 25kg/m2 7. Able and willing to give informed consent 8. Able to understand English
Exclusion criteria
Exclusion criteria: 1. Females who are not postmenopausal (as menstrual cycle can affect appetite hormone concentrations) which is defined as “2 years post last menstrual period 50 years of age.” 2. Type 2 diabetes on any other glucose lowering treatment except metformin 3. Patients with Type 1 diabetes 4. Patients on loop diuretics 5. Age 70 years 6. BMI 86mmol/mol (10%), recent hospital admission with diabetic emergency in last 3 months 11. Patients with familial renal glycosuria 12. Patients with recurrent balanitis, vaginal or urinary tract infections 13. Shift workers 14. Patients who have participated in another study of an investigational medicinal product in the last 3 months 15. Active malignancy 16. Serious illness with a life-expectancy of less than 1 year 17. Hypersensitivity to Empagliflozin (Jardiance™) or to any of the excipients 18. Patients with latent autoimmune diabetes in adults (LADA) 19. Patients with a history of chronic pancreatitis 20. Evidence of conditions that lead to restricted food intake or severe dehydration 21. Patients with a history of excessive alcohol consumption 22. Patients on a severely calorie restricted diet (i.e., =800 calories per day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Peptide Y-Y (PYY) concentration in blood samples is measured 8 times per visit at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ghrelin and GLP-1 concentration in blood samples is measured 8 times per visit at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks 2. 2. Weight and body composition is measured by DEXA scanning at baseline and 24 weeks 3. Resting energy expenditure is measured using indirect calorimetry at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks 4. Physical activity is measured using physical activity monitors at the familiarisation visit and at 6 weeks, 12 weeks and 24 weeks 5. Full Blood Count, Urea & Electrolytes, Liver Function Test, lipids, HbA1c, C-Reactive Protein, Urine Glucose Excretion, Fasting Plasma Glucose, Free Fatty Acids will be measured once per visit at the familiarisation visit and at 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks 6. Insulin, glucose, glucagon and leptin will be measured 8 times per visit 0 weeks, 2 weeks, 6 weeks, 12 weeks and 24 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed