COCONUT (Version 1.0)

• Research type

  Research Study

• Full title

  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

• IRAS ID

  265246

• Contact name

  Ian Wilkinson

• Contact email

  ibw20@medschl.cam.ac.uk

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  What is the research question?
  The study aims to study the cardiovascular effects of glucagon-like peptide-1 (GLP-1) and glucagon. Intravenous infusions (drips in the arm) will be given to patients with type 2 diabetes whilst they undergo a series of scans. These scans will include Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The PET scan allows us to form an image of how cells in the heart function, whilst the MRI scan gives us the structure of the heart or liver.

  Who is eligible?
  Overweight patients with type 2 diabetes mellitus (T2DM) over the age of 18 years of age.

  What is being studied?
  Naturally occurring human peptides: GLP-1 and Glucagon – these will be intravenously infused through a cannula (drip in the arm) whilst the patient undergoes (PET) MRI imaging

  What is the relevance and importance to patients with type 2 diabetes?
  GLP-1 based drugs (i.e. Exenetide / Liraglutide) are licensed for the treatment of T2DM and help to normalise (i.e. 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 receptors) are being investigated for the treatment of diabetes and obesity. I will be studying the role these endogenous substances have on the following - cardiac function, the energy or ‘fuel’ source of the heart, oxygen use/blood flow in the heart and concentration of glycogen within the liver.

  Where will the study take place?
  The study will be conducted at Addenbrooke's Hospital in Cambridge.

  How many study visits are there?
  There are four parts to the study. Parts A and B each consist of four imaging visits. There is one imaging visit for Part C and two for Part D.

  How long will the study last?
  In total the study is expected to last approximately up to five years.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  19/SW/0168

• Date of REC Opinion

  28 Aug 2019

• REC opinion

  Favourable Opinion