Investigating cardiac energy levels in people with lean-type type 2 diabetes

Phase 4

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN85605342
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-16
• Last Update Posted: 4 October 2021
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 56

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified