The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance.

September 29, 2025 updated by: Ali Asmar, Bispebjerg Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Glucagon
Drug: 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.
Drug: 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, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes
Drug: Sodium chloride
Placebo (0.9% NaCl).
Experimental: Glucagon+Exendin9-39
Drug: 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.
Drug: 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, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes
Drug: Sodium chloride
Placebo (0.9% NaCl).
Placebo Comparator: Sodium chloride (Placebo comparator)
Drug: 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.
Drug: 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, plus a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-¹·min-¹), given intravenously from -30 to 60 minutes
Drug: Sodium chloride
Placebo (0.9% NaCl).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-24012271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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