Cardio and Renovascular Effects of Isometric Exercise in the Healthy Human Measured by PET/CT and MRI

August 12, 2024 updated by: Ali Asmar, Bispebjerg Hospital

Cardio and Renovascular Effects of Static Muscle Work in the Healthy Human - Measured With Finapres® and Positron Emission Tomography (PET) Using 15-oxygen Labeled Water as Tracer Compared to Magnetic Resonance (MR)

This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PET/CT, using 15-oxygen labeled water as tracer, against the validated multiparametric MRI technique.

The study will determine:

  • Total renal blood flow and regional renal perfusion at baseline (rest) and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
  • The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
  • Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI.
  • The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Measuring tissue perfusion with PET/CT using 15-oxygen labeled water is routinely used as a non-invasive tool to examine cerebral and myocardial perfusion. With a 100% tissue extraction, 15-oxygen labeled water is gold standard.

The aim of the present study is to validate renal perfusion measurements with PET/CT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique.

Once validated the imaging technique will be beneficial in examining vascular damage in the kidneys caused by different renal diseases.

This is a randomized, crossover study where each participant will participate in 1 study day.

Ten healthy male participants in the age group 20-60 years are screened and randomized, and expected to complete the present study. Informed consent is obtained before the screening meeting.

All participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol + 2 mmol/kg sodium for 4 days before the experiment. On the fourth day, 24-hour urine collection will be performed. Throughout the 4 day period, water intake will be ad libitum and physical activity will not be allowed.

Each participant will undergo both PET/CT and MRI separated by around 1.5 hour.

Total renal blood flow and regional renal perfusion are measured repeatedly altogether 5 times with both PET/CT and MRI. Renal oxygenation and oxygen extraction are measured repeatedly 5 times as well, using MRI. The 5 measurements consist of 2 at baseline (rest), 2 during isometric exercise (handgrip) and 1 during recovery (rest).

Isometric muscle exercise is conducted by squeezing a handgrip coupled to a dynamometer. This increases sympathetic nervous activity, leading to preglomerular vasoconstriction.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2400
        • Recruiting
        • Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine
        • Contact:
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Normal health stated through medical questionnaire, examination and blood samples.

Exclusion Criteria:

  • Immunosuppressive treatment
  • Alcohol abuse
  • Treatment with glucocorticoids, Glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase 4 (DPP-4)-inhibitors
  • Medical treatment affecting insulin secretion or cardiovascular endpoints
  • Liver disease
  • Decreased kidney function
  • Severe claustrophobia
  • Elements incompatible with MR.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group randomized to begin with MRI
Group is randomized to begin with MRI and have PET/CT performed later on the same day
Procedure: MRI
MRI will be performed
Procedure: PET/CT
PET/CT will be performed
Other: Group randomized to begin with PET/CT
Group is randomized to begin with PET/CT and have MRI performed later on the same day
Procedure: MRI
MRI will be performed
Procedure: PET/CT
PET/CT will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET/CT with 15-Oxygen labeled water and MRI
Time Frame: Each participant's study day during the span of the study (approximately 5 months)
No metric unit
Each participant's study day during the span of the study (approximately 5 months)
Total blood flow at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
Time Frame: Each participant's study day during the span of the study (approximately 5 months)
Volume of blood pr unit time, ml/min
Each participant's study day during the span of the study (approximately 5 months)
Regional renal perfusion at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
Time Frame: Each participant's study day during the span of the study (approximately 5 months)
Volume of blood pr unit time pr unit tissue mass, ml/min/g
Each participant's study day during the span of the study (approximately 5 months)
Regional renal oxygenation at rest and during isometric muscle exercise using MRI
Time Frame: Each participant's study day during the span of the study (approximately 5 months)
Percentage, fraction
Each participant's study day during the span of the study (approximately 5 months)
Regional renal extraction of oxygen at rest and during isometric muscle exercise using MRI
Time Frame: Each participant's study day during the span of the study (approximately 5 months)
Percentage, fraction
Each participant's study day during the span of the study (approximately 5 months)
Coefficient of variation on regional renal oxygenation and extraction of oxygen measurements at rest and isometric muscle exercise using MRI
Time Frame: Each participant's study day during the span of the study (approximately 5 months)
No metric unit
Each participant's study day during the span of the study (approximately 5 months)

Collaborators and Investigators

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

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Ali Asmar, MD, PhD, Bispebjerg Hospital, Department of Clinical Physiology and Nuclear Medicine

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)

May 7, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-23037460

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.

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