- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06872060
The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance.
This study will investigating the effects of glucagon on renal blood flow in humans using MRI technology. Glucagon, a hormone produced by the pancreas, plays a key role in regulating blood sugar levels. It has been shown to affect renal function, including electrolyte balance and blood flow, especially in conditions like type 2 diabetes where abnormal glucagon levels are common. The study aims to understand how glucagon affects regional blood flow in the kidneys, specifically the cortex and medulla, and whether these effects are mediated by glucagon receptors.
The study will be conducted on 10 healthy male participants aged 20-60 years. It involves three test days where participants will receive either glucagon, glucagon with a GLP-1 receptor antagonist, or placebo. Blood flow, glomerular filtration rate, and other renal functions will be measured using MRI. The study seeks to clarify whether glucagon's effects on the kidneys are linked to changes in regional blood flow and to determine if these effects are mediated solely by glucagon receptors.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Normal health confirmed through; Interview and Medical examination
- Normal values with respect to blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, HDL, LDL, creatinine, liver function tests, and electrolytes
- Informed consent
Exclusion Criteria:
- Immunosuppressive treatment in the previous 12 months
- Alcohol abuse
- Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists, which, in the opinion of the principal investigator, may interfere with glucose metabolism
- Use of lithium
- Medical treatment that affects insulin secretion or the renin-angiotensin-aldosterone system
- Liver disease (ALT > 2x normal value)
- Renal impairment (serum creatinine > 130 µM and/or albuminuria)
- Individuals with severe claustrophobia
- Individuals with MR-incompatible foreign bodies
- Individuals with hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glucagon
|
Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes.
Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes
Placebo (0.9% NaCl).
|
|
Experimental: Glucagon+Exendin9-39
|
Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes.
Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes
Placebo (0.9% NaCl).
|
|
Placebo Comparator: Sodium chloride (Placebo comparator)
|
Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes.
Glucagon infusion at 5 ng·kg-¹·min-¹ from 0-30 minutes and 10 ng·kg-¹·min-¹ from 30-60 minutes, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes
Placebo (0.9% NaCl).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood perfusion of the kidney
Time Frame: 7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).
|
we would like to measure blood perfusion of the kidneys over time
|
7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood flow of the renal arteries
Time Frame: 7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).
|
7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).
|
|
blood oxygen saturation of the kidneys
Time Frame: 7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).
|
7 measurements of 10 minutes each from the start of infusion (time 0) and up to one hour (time 60).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Kidney Diseases
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Peptide Hormones
- Peptides
- Amino Acids, Peptides, and Proteins
- Inorganic Chemicals
- Chlorine Compounds
- Pancreatic Hormones
- Sodium Compounds
- Proglucagon
- Chlorides
- Hydrochloric Acid
- Glucagon
- Sodium Chloride
Other Study ID Numbers
- H-24012271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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