COCOA (Version 1.0)
Research type
Research Study
Full title
A Comparison of the Haemodynamic and Metabolic Effects of Intravenous Glucagon-like Peptide-1, Glucagon and Glucagon-like Peptide-1:Glucagon Co-agonism in Healthy Male Participants
IRAS ID
250402
Contact name
Ian Wilkinson
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
WHAT IS THE RESEARCH QUESTION?
The study aims to study the cardiovascular and metabolic effects of Glucagon-like peptide-1 (GLP-1) and Glucagon, both alone, and in combination (referred to in this document as GLP-1:glucagon). Intravenous infusions will be given to healthy male subjects. Non-invasive cardiovascular measurements (including blood pressure, heart rate) and bloods (including insulin, blood glucose, GLP-1, glucagon etc) will be collected as part of the study.WHAT IS BEING STUDIED
Naturally occurring human peptides: GLP-1 and Glucagon, both alone, and in combination.HOW IS IT OF RELEVANCE AND IMPORTANCE TO PATIENTS AND PUBLIC?
GLP-1 agonists (ie exenetide) are established for the treatment of type 2 diabetes mellitus (T2DM) and help to normalise (ie reduce) blood sugar levels. Glucagon is an established treatment for hypoglycaemia (low blood sugar). Co-agonist peptides (implying action at both GLP-1 or glucagon) are being investigated for the treatment of diabetes and obesity. I will be studying the role these endogenous substances play in haemodynamic regulation.WHO IS ELIGIBLE?
Healthy male volunteers between the ages of 18-40.WHERE WILL THE STUDY TAKE PLACE?
The study will be conducted at the Addenbrooke's Hospital, Cambridge.HOW LONG WILL THE STUDY LAST?
Each volunteer will attend screening followed by 5 visits. We plan to recruit up to 20 volunteers. The study will last for approximately three years.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0417
Date of REC Opinion
15 Jan 2019
REC opinion
Further Information Favourable Opinion