DRUG
Saline 0.9%
Intravenous infusion of 0.9% saline
Haemodynamic Effects of GLP-1 and Glucagon in Healthy Male Volunteers
Status
Completed
Phase
Not applicable
Enrollment
26
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 two peptide receptors, GLP-1 and glucagon. Glucagon, exenatide and 0.9% saline will be intravenously infused, both in isolation, and combination into healthy male participants. Overall, the aim of the study is to further our understanding on the role these endogenous substances play (both in isolation and combination) in haemodynamic regulation.
Full detailed description
Co-agonist peptides (such as at the GLP-1:glucagon receptor) are currently in clinical development for type 2 diabetes with the dual intention of reducing body weight and controlling blood glucose. However, there is a lack of data on the effects that co-agonism has on haemodynamic regulation. Part A - Healthy male participants, by acting as their own control, will attend for two intravenous infusion visits (combination of 0.9% saline and glucagon). These will occur in a predefined but random order so that participants will be blinded to the infusion they are receiving. Each infusion visit will comprise of 15 minute baseline followed by a 120 minute infusion. Detailed non-invasive cardiovascular measurements (including peripheral/central blood pressure, heart rate, stroke volume, heart rate variability) and bloods (including insulin, glucose, GLP-1, glucagon) will be collected as part of the study. It was previously planned that GLP-1 7-36 amide 0.6pmol/kg/min and 1.2pmol/kg/min would be infused for Part A resulting in 5 infusions (rather than current 2 infusions). However due to supply/technical issues this was not possible and therefore exenatide (GLP-1 receptor agonist) shall be used in Part B. Part B - Healthy male participants, by acting as their own control, will attend for four intravenous infusion visits (combination of 0.9% saline, glucagon, exenatide). These will occur in a predefined but random order so that participants will be blinded to the infusion they are receiving. Each infusion visit will comprise of 15 minute baseline followed by a 60 minute infusion. Detailed non-invasive cardiovascular measurements (including peripheral/central blood pressure, heart rate, stroke volume, heart rate variability) and bloods (including insulin, glucose, GLP-1, glucagon) will be collected as part of the study.
Interventions
Treatment arms and agents.
DRUG
Glucagon (25ng/kg/min)
Intravenous infusion of glucagon 25ng/kg/min
DRUG
Glucagon (50ng/kg/min)
Intravenous infusion of glucagon 50ng/kg/min
DRUG
Exenatide
Intravenous infusion of Exenatide (loading 50ng/min for 30 minutes followed by 25ng/min for 30 minutes
Timeline
From registration to results.
First posted
Feb 8, 2019
Study start
Feb 11, 2019
Primary completion
Nov 1, 2021
Study completion
Nov 1, 2021
Results posted
Not reported
Registry updated
Apr 3, 2024
Outcomes
What the study measures.
Primary outcomes
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Heart rate (bpm)
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Brachial systolic and diastolic blood pressure (mmHg)
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Central systolic and diastolic blood pressure and mean arterial pressure (mmHg) measured with SphygmoCor XCEL
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Stroke volume (ml) measured by bioimpedance
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Cardiac output (L/min) measured by bioimpedance
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
peripheral vascular resistance (dynes/sec/cm)
Changes in haemodynamic parameters following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Heart rate variability (normalised low frequency, LF, high frequency, HF and LF/HF ratio)
Secondary outcomes
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-5 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Glucose, in mmol/L
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
C-peptide, in pmol/L
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Glucagon, in pg/ml
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Insulin, in pmol/L
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Free fatty acids, in μmol/L
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Total GLP-1 and total active GLP-1, in pg/ml
Changes in glucose homeostasis following intravenous infusion of 0.9% saline, glucagon, exenatide and their combination.
Time frame · Comparison between 2 hour infusion visit 1-2 (Part A) / 1 hour infusion visit 1-4 (Part B), over a maximum period of 15 weeks
Gastric inhibitory polypeptide, in pg/ml
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 40 Years
- Sex
- MALE
- Healthy volunteers
- Yes
Inclusion Criteria: * Written informed consent to participate * Aged 18 to 40 * Male * Current non-smoker * BMI \>18.0 and \<30kg/m2 Exclusion Criteria: * Female * Sustained Hypertension (sustained BP \>160/100mmHg) or hypotension (systolic BP below 90 mmHg) * Clinically significant heart disease * Implanted heart pace-maker or implantable cardioverter defibrillator (ICD) * Known active malignancy * Known renal failure (creatinine \>140μmol/L) * Known diabetes mellitus (type 1 or 2) * Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits * Use of formal anticoagulant therapy such as, but not limited to, heparin, warfarin or rivaroxaban * Current involvement in the active treatment phase of other research studies, (excluding observations/noninterventional) * 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.
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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