Cardio and Renovascular Effects of Isometric Exercise in the Healthy Human Measured by PET/CT and MRI
NCT ID: NCT06555211
Last Updated: 2024-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-05-07
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Group randomized to begin with MRI
Group is randomized to begin with MRI and have PET/CT performed later on the same day
MRI
MRI will be performed
PET/CT
PET/CT will be performed
Group randomized to begin with PET/CT
Group is randomized to begin with PET/CT and have MRI performed later on the same day
MRI
MRI will be performed
PET/CT
PET/CT will be performed
Interventions
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MRI
MRI will be performed
PET/CT
PET/CT will be performed
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
60 Years
MALE
Yes
Sponsors
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Bispebjerg Hospital
OTHER
Responsible Party
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Ali Asmar
Chief Physician, Associate Professor
Principal Investigators
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Ali Asmar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital, Department of Clinical Physiology and Nuclear Medicine
Locations
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Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine
Copenhagen, Capital Region, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-23037460
Identifier Type: -
Identifier Source: org_study_id
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