Status:
COMPLETED
Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants with Type 2 Diabetes
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Antaros Medical
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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...
Detailed Description
This is a single-centre, single-blinded pilot study designed to understand the role the GLP-1 receptor agonist, exenatide, and glucagon receptor co-agonism has on normal cardiac physiology, myocardial...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04307797
Start Date
January 18 2022
End Date
October 7 2022
Last Update
September 19 2024
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ