Cardio and Renovascular Effects of Isometric Exercise in the Healthy Human Measured by PET/CT and MRI
ConditionKidneys
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorBispebjerg Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Normal health stated through medical questionnaire, examination and blood samples.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
MRI
Procedure/SurgeryMRI will be performed
PET/CT
Procedure/SurgeryPET/CT will be performed
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Group randomized to begin with MRIOther 2 interventions
Group B: Group randomized to begin with PET/CTOther 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Each participant's study day during the span of the study (approximately 5 months)2
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
Time frame
Each participant's study day during the span of the study (approximately 5 months)3
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
Time frame
Each participant's study day during the span of the study (approximately 5 months)4
Regional renal oxygenation at rest and during isometric muscle exercise using MRI
Percentage, fraction
Time frame
Each participant's study day during the span of the study (approximately 5 months)Sponsors and contacts
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Source ClinicalTrials.gov