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Active Not RecruitingNCT04754581

Dynamic in Vivo PET Imaging and ex Vivo Biopsies From Skeletal Muscle and Adipose Tissue to Investigate the Effects of Exercise on Insulin Resistance and Mitochondrial Energetics in Type 2 Diabetes

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
39 (actual)
Sponsor
AdventHealth Translational Research Institute · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Accepted

Summary

The overall aim of this pilot study is to investigate the effects of exercise training on skeletal muscle and adipose tissue insulin resistance in subjects with Type 2 Diabetes (T2D).

Conditions

Interventions

TypeNameDescription
OTHERMaximal ATP Production (ATPmax)ATPmax will be measured in order to determine in vivo mitochondrial capacity. The magnetic resonance scans to measure mitochondrial energetics will also be performed.
OTHERExercise Testing (VO2max)Aerobic fitness level will be assessed while participant pedals on a stationary bicycle/walk on a treadmill. The volume of oxygen intake and carbon dioxide (CO2) production will be measured.
PROCEDUREMuscle BiopsySample muscle cells from the left leg Vastus Lateralis (thigh) muscle.
PROCEDUREAdipose Tissue BiopsySample fat tissue from the abdomen.
OTHERHyperinsulinemic euglycemic clampMeasurement of insulin sensitivity.
OTHERPET imagingAfter an overnight fast, an intravenous catheter will be placed in each arm (one with arterial line for PET infusion, and the other for infusion of insulin, glucose, and 6,6 D2 glucose tracer. FDG-glucose will be injected followed by 90-minute PET scanning of the thigh.

Timeline

Start date
2021-03-30
Primary completion
2025-08-15
Completion
2026-12-01
First posted
2021-02-15
Last updated
2026-03-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04754581. Inclusion in this directory is not an endorsement.