Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants With Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study seeks to explore the cardiovascular effects of co-agonism at the glucagon and (glucagon-like peptide-1) GLP-1 receptor. Glucagon and exenatide will be intravenously infused into participants with type 2 diabetes (T2DM). Overall, the aim of the study is to further the investigator's understanding on the role these endogenous substances have on normal cardiac physiology, myocardial energetics and myocardial glucose uptake through a series of PET and MRI imaging studies

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Antaros Medical; Antaros Medical AB
• Treatments: Exenatide; Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Written informed consent to participate

• Aged >18 years

• Clinical diagnosis of T2DM, either diet controlled or treated with metformin (to be withheld on the morning of the imaging visit)

• BMI ≥25kg/m2

• Current non-smoker

Exclusion Criteria:

• Females of childbearing potential (Part A only) / current pregnancy (all parts)

• Sustained Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)

• Clinically significant heart disease

• Implanted heart pacemaker or implantable cardioverter defibrillator (ICD)

• Known active malignancy other than skin cancer

• Known renal failure (creatinine >150µmol/L)

• Known type one diabetes mellitus / known or clinically suspected diagnosis of a monogenic form of diabetes

• Poorly controlled blood glucose

• Current daily use of anti-diabetic medication including Insulin, GLP-1 based agonists, DPP4i or any other medication known to interact with either of the study drugs (exenatide or glucagon)

• Current involvement in the active treatment phase of other research studies, (excluding observational/non-interventional).

• Contraindication for MRI/PET scan, i.e. any reason which precludes MRI imaging according to local policy (ie internal pacemaker/defibrillator, metal fragments, claustrophobia)

• Participation in research studies in the last 3 years involving radiation (if the effective dose exceeded 10mSv). This does not include any diagnostic or therapeutic exposures which were clinically justified.

• Any other clinical reason which may preclude entry in the opinion of the investigator