Acute Effects of GLP-1 on Renal Hemodynamics (GLP1RRBF)

April 3, 2020 updated by: Ali Asmar, Rigshospitalet, Denmark

Acute Effects of GLP-1 on Renal Hemodynamics: Simultaneous Perfusion and Oxygenation Measurements in Cortex and Medulla Using Magnetic Resonance Imaging

This study investigates the hypothesis, that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Human studies have recently demonstrated a significant natriuretic effect of GLP-1 when the extracellular fluid volume (ECFV) is expanded by intravenous sodium-loading; in these studies, there was a suppression of ANG II with no change in net renal hemodynamics, pointing to a tubular mechanism for reduced NaCl reabsorption secondary to the ANG II suppression. In the current randomized and controlled study, investigators aim to test the hypothesis that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation. Thus, contributing to the renoprotective action of GLP-1.

Under fixed sodium intake for 4 days before each study day, 10 healthy male participants will be investigated during a 1-hour infusion of GLP-1 (1.5 pmol/kg/min) or vehicle together with an intravenous infusion of 0.9% NaCl. Interleaved measurements of RAF, oxygenation (T2*) and perfusion by arterial spin labeling in the renal cortex and medulla at fixed time points will be conducted, using Magnetic Resonance Imaging (MRI).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Glostrup, Copenhagen, Denmark, 2600
        • Rigshospitalet - Glostrup

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

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Normal health demonstrated by medical examination.
  • Normal values for fasting plasma glucose, total cholesterol, triglyceride, HDL, LDL, creatinine, AST, ALT and electrolyte concentrations.

Exclusion Criteria:

  • Immunosuppressive treatment for the previous 12 months.
  • Alcohol abuse.
  • Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists that, in the opinion of the investigator, may interfere with glucose metabolism.
  • Use of lithium.
  • Medical treatment that affects insulin secretion or cardiovascular efficacy goals.
  • Liver disease (ALT> 2 x normal value).
  • Renal impairment (creatinine> 130 µM and / or albuminuria).
  • Severe claustrophobia.
  • MRI incompatible foreign bodies.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: human glucagon-like peptide-1

Intervention:

Drug: human glucagon-like peptide-1 Other names: GLP-1
Drug: Glucagon-Like Peptide 1
Intravenous infusion (1.5 pmol/kg/min) for 60 min.
Other Names:
  • GLP-1
Placebo Comparator: Placebo

Intervention:

Drug: Placebo (saline) Other names: Placebo for human glucagon-like peptide-1
Drug: saline 0.9%
Intravenous infusion for 60 min.
Other Names:
  • Placebo for GLP-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T2* signal
Time Frame: 1 hour
Changes in T2* signal in renal cortex and medulla
1 hour
Arterial Spin Labeled (ASL)
Time Frame: 1 hour
Changes in Arterial Spin Labeled (ASL) MRI Perfusion Imaging in renal cortex and medulla
1 hour
Renal Artery Flow Phase (RAF)
Time Frame: 1 hour
Changes in Renal Artery Flow Phase (RAF)-Contrast Magnetic Resonance
1 hour

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Collaborators

Department of Cardiovascular and Renal Research, University of Southern Denmark

Investigators

  • Principal Investigator: Ali Asmar, MD, PhD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18050603

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

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.

Clinical Trials on The GLP-1-mediated Gut-kidney Axis

Clinical Trials on Glucagon-Like Peptide 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe