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

NCT06555211 | Recruiting

• 1 other identifier: H-23037460
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidneys

Keywords

Total renal blood flow; Regional renal perfusion; Regional renal oxygenation; Renal oxygen extraction

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  No metric unit

  Each participant's study day during the span of the study (approximately 5 months)

Study Arms (2)

Group randomized to begin with MRI

OTHER

Group is randomized to begin with MRI and have PET/CT performed later on the same day

Procedure: MRI; Procedure: PET/CT

Group randomized to begin with PET/CT

OTHER

Group is randomized to begin with PET/CT and have MRI performed later on the same day

Procedure: MRI; Procedure: PET/CT

Interventions

MRI PROCEDURE

MRI will be performed

Group randomized to begin with MRI; Group randomized to begin with PET/CT

PET/CT PROCEDURE

PET/CT will be performed

Group randomized to begin with MRI; Group randomized to begin with PET/CT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine

Copenhagen, Capital Region, 2400, Denmark

RECRUITING

Study Officials

• Ali Asmar, MD, PhD

  Bispebjerg Hospital, Department of Clinical Physiology and Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Sørensen, MD

CONTACT

+4530516279; peter.soerensen@regionh.dk

Ali Asmar, MD, PhD

CONTACT

ali.asmar@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Associate Professor

Model Details: Each participant will undergo intervention, which is PET/CT, and control, which is MRI. Each participant will have both intervention and control performed the same day in randomized order.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 15, 2024
• Study Start: May 7, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

DK (1)