Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
This is a single centre, open-label, randomized, cross-over study. Participants will attend 4 visits in total over the course of approximately 40 weeks. Two cohorts of patients will be recruited: 28 l
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Lean cohort: 1. Men and women >18 years of age 2. Normal body weight 18.5 = BMI =25 kg/m² 3. T2D patients can be on treatment with oral glucose-lowering therapies, and if they are, they must have been on these treatments for at least 12 weeks prior to screening 4. 6.5 = HBA1c = 10% at screening 5. Agreement to maintain prior diet and exercise habits for the duration of the study Overweight cohort: 1. Men and women >18 years of age 2. Increased body weight BMI >27 kg/m² 3. T2D patients can be on treatment with oral glucose-lowering therapies, and if they are, they must have been on these treatments for at least 12 weeks prior to screening 4. 6.5 = HBA1c = 10% at screening 5. Agreement to maintain prior diet and exercise habits for the duration of the study
Exclusion criteria
Exclusion criteria: All cohorts: 1. Any type of diabetes other than T2D 2. Past history of significant CAD 3. Known HF 4. Significant renal impairment (eGFR< 30ml/min/m²) 5. Participation in a clinical trial of an investigational medicinal product in the preceding 12 weeks 6. Known hypersensitivity to dobutamine or gadolinium or any other contra-indications to MRI 7. Participants with obesity where their girth exceeds the scanner bore 8. History of pancreatitis 9. Any history of liver disease 10. Patients with Multiple Endocrine Neoplasia syndrome type 2 11. Prior or current use of thiazolidinediones (aka PPAR-gamma agonists), fibrates, GLP-1RA or insulin 12. Patients with high serum calcitonin levels at baseline 13. Patients that are pregnant (female participants only) 14. Inflammatory bowel disease 15. Diabetic gastroparesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial perfusion measured by MRI at baseline and 16-weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline and 16-weeks: 1. Myocardial energetics (PCr/ATP ratio), measure by MRI spectroscopy. 2. Myocardial steatosis (myocardial triglyceride content), measured by MRI spectroscopy 3. Myocardial function, measured by MRI 4. Insulin resistance (HOMA-IR) measured by blood test 5. Physical performance, measure by 6 minute walk test 6. Hepatic triglyceride content, measured by blood test 7. Peripheral endothelial function, measure by the EndoPAT machine | — |
Countries
England, United Kingdom
Outcome results
None listed