A Pilot Study on the Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants with Type 2 Diabetes (COCONUT)

Registration

Registration

NCT04307797

Acronym

COCONUT

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE4

Masking

SINGLE

Status

COMPLETED

Enrollment

10

Start

2022-01-18

Primary completion

2022-10-07

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Conditions

Type 2 Diabetes; Obesity

Interventions

DRUG:0.9% Sodium-chloride; DRUG:Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min; DRUG:Glucagon 12.5ng/kg/min and 0.9% saline; DRUG:Glucagon 12.5ng/kg/min

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• Part A - Myocardial glucose uptake [Comparison between scans over a maximum period of 16 weeks]
• Part A - Global longitudinal strain / global circumferential strain / global radial strain [Comparison between scans over a maximum period of 16 weeks]
• Part A - Ejection fraction [Comparison between scans over a maximum period of 16 weeks]
• Part A - Stroke volume [Comparison between scans over a maximum period of 16 weeks]
• Part A - Cardiac output [Comparison between scans over a maximum period of 16 weeks]
• Part B - Changes in phosphocreatine/adenosine (PCr/ATP) radio [Comparison between scans over a maximum period of 16 weeks]
• Part B - Changes in absolute concentrations of PCr and ATP defined by AHA 17- segment territory as a measure of cardiac energy status (determined by 31P-MRS) [Comparison between scans over a maximum period of 16 weeks]