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NCT04307797·Phase 4·INTERVENTIONAL

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

ExenatideWeight lossType 2 diabetesCompleted

Status

Completed

Phase

Phase 4

Enrollment

10

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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 energetics and myocardial glucose utilisation. Part A - Overweight participants with type 2 diabetes will act as their own control and will undergo a series of three imaging studies (in a randomised order) as detailed below: 1. Cardiac positron emission tomography-magnetic resonance imaging (PET-MRI) with fluorine-18-fluorodeoxyglucose (18F-FDG) with placebo (0.9% saline) infusion 2. Cardiac PET-MRI with 18F-FDG with co-infusion of exenatide and glucagon 3. Cardiac PET-MRI with 18F-FDG with infusion of glucagon Part B - Overweight participants with type 2 diabetes will act as their own control and will undergo a series of two imaging studies (in a randomised order), followed by one optional visit as detailed below: 1. 7T Phosphorus (P) 31 magnetic resonance spectroscopy (MRS) (31P-MRS) with placebo (0.9% saline) infusion 2. 7T 31P-MRS with co-infusion of glucagon and exenatide 3 (optional) 7T 31P-MRS with infusion of glucagon Study outcome measures are detailed below

Interventions

Treatment arms and agents.

DRUG

0.9% Sodium-chloride

Part A - 0.9% saline infusion during cardiac PET-MRI scan

DRUG

Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min

Part A - exenatide and glucagon infusion during cardiac PET-MRI scan

DRUG

Glucagon 12.5ng/kg/min and 0.9% saline

Part A - Glucagon and 0.9% saline infusion during PET-MRI scan

DRUG

0.9% Sodium-chloride

Part B - 0.9% saline infusion during 7T 31P MRS scan

DRUG

Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min

Part B - exenatide and glucagon infusion during 7T 31P MRS scan

DRUG

Glucagon 12.5ng/kg/min

Part B - Glucagon infusion during 7T 31P MRS scan

Timeline

From registration to results.

  1. First posted

    Mar 13, 2020

  2. Study start

    Jan 18, 2022

  3. Primary completion

    Oct 7, 2022

  4. Study completion

    Oct 7, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Sep 19, 2024

Outcomes

What the study measures.

Primary outcomes

Part A - Myocardial glucose uptake

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in myocardial glucose uptake between 0.9% saline, glucagon:exenatide and glucagon scan as measured by 18F-FDG

Part A - Global longitudinal strain / global circumferential strain / global radial strain

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in global longitudinal strain / global circumferential strain / global radial strain between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part A - Ejection fraction

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in ejection fraction between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part A - Stroke volume

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in stroke volume between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part A - Cardiac output

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in cardiac output between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part B - Changes in phosphocreatine/adenosine (PCr/ATP) radio

Time frame · Comparison between scans over a maximum period of 16 weeks

Changes in PCr/ATP radio between 0.9% saline, glucagon:exenatide and glucagon (optional) in the mid-interventricular septum as a measure of cardiac energy status as measured by 7T phosphorus (P) 31 magnetic resonance spectroscopy (MRS)

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)

Time frame · Comparison between scans over a maximum period of 16 weeks

Changes in absolute concentrations of PCr and ATP between 0.9% saline, glucagon:exenatide and glucagon (optional) as defined by AHA 17-segment territory as a measure of cardiac energy status (determined by 7T 31P-MRS)

Secondary outcomes

Part A - End systolic/diastolic ventricular/atrial volumes

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in end systolic/diastolic ventricular/atrial volumes between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part A - Radial strain

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in radial strain between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part A - Global systolic/diastolic longitudinal/circumferential/radial strain rate

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in global systolic/diastolic longitudinal/circumferential/radial strain rate between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part A - Relationship between early and late filling (from mitral flow)

Time frame · Comparison between scans over a maximum period of 16 weeks

Difference in early and late filling (from mitral flow) between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR

Part A/B - Heart rate

Time frame · Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Difference in heart rate between 0.9% saline, glucagon:exenatide and glucagon

Part A/B - Blood pressure

Time frame · Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Difference in blood pressure between 0.9% saline, glucagon:exenatide and glucagon

Part A/B - Glucose

Time frame · Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Difference in glucose between 0.9% saline, glucagon:exenatide and glucagon

Part A/B - Glucagon

Time frame · Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Difference in glucagon between 0.9% saline, glucagon:exenatide and glucagon

Part A/B - Insulin

Time frame · Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Difference in insulin between 0.9% saline, glucagon:exenatide and glucagon

Part A/B - C-peptide

Time frame · Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks

Difference in C-peptide between 0.9% saline, glucagon:exenatide and glucagon

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
99 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge

Cambridge, Cambridgeshire, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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