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Clinical Trial NCT04754581 (EXPET) for Type 2 Diabetes is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 (EXPET)

Recruiting
Clinical Trial NCT04754581 (EXPET) is an interventional study for Type 2 Diabetes that is recruiting. It started on March 30, 2021 with plans to enroll 12 participants. Led by AdventHealth Translational Research Institute, it is expected to complete by June 1, 2025. The latest data from ClinicalTrials.gov was last updated on September 27, 2024.
Brief 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).
Official Title

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

Conditions
TYPE 2 Diabetes
Other Study IDs
  • EXPET
  • 1581803
NCT ID Number
NCT04754581
Start Date (Actual)
2021-03-30
Last Update Posted
2024-09-27
Completion Date (Estimated)
2025-06
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherAll Participants
Maximal 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.
Exercise 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.
Muscle Biopsy
Sample muscle cells from the left leg Vastus Lateralis (thigh) muscle.
Adipose Tissue Biopsy
Sample fat tissue from the abdomen.
Hyperinsulinemic Euglycemic Clamp
Measurement of insulin sensitivity.
PET Imaging
After 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Individual steps of muscle glucose uptake (pre-exercise)
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
24 hours
Individual steps of muscle glucose uptake (post-exercise)
Muscle glucose uptake will be assessed two times (pre and post exercise intervention) on the biceps femoris and vastus lateralis through PET imaging and hyperinsulinemic euglycemic clamp.
24 hours
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. Age 30-65 years
  2. Men and women
  3. Body mass index (BMI) between 25 and 45 kg/m2
  4. Sedentary (1 day or less per week of structured exercise)
  5. Type 2 diabetes mellitus determined by self-report or by a fasting glucose >126mg/dl
  6. Weight stable (± 2 kg) for prior 3 months
  7. Willing to commit to the schedule of assessment visits, including the exercise intervention

  1. Currently taking insulin, injectable incretin mimetics and thiazolidinediones
  2. Taking more than two glucose-lowering medications
  3. Resting blood pressure ≥ 160/100 mm Hg
  4. Triglycerides ≥ 500 mg/dL
  5. Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise training protocol
  6. Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
  7. Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise training
  8. Pulse check ("Allen test") indicates participant has poor blood flow in the hands
  9. Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)
  10. Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year
  11. Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
  12. Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
  13. Participant is currently taking anti-inflammatory medication or has had inflammatory medication within 1 week prior to screening (including over the counter formulations: e.g. Aleve, Motrin, Ibuprofen, Naproxen, low dose ASA.
  14. New onset (<3 months on a stable regime) hormone replacement therapy
  15. Current use of beta-adrenergic blocking agents
  16. Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
  17. Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
  18. Abnormal blood count/anemia, blood transfusion or blood donation within the last 2 months
  19. Current smokers (smoking within the past 3 months prior to screening visit, including any/all tobacco products)
  20. Current drug or alcohol abuse/dependence
  21. Metal implants (pace-maker, aneurysm clips) based on investigator's judgment at screening
  22. Not physically capable of performing the exercise required of the study protocols
  23. Plans to be away >2 weeks in the next 3 months
  24. Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.
  25. Unable to tolerate MRI or claustrophobia.
  26. Nickel allergy
  27. Lidocaine allergy
  28. Unable or unwilling to communicate with staff or to provide written informed consent
AdventHealth Translational Research Institute logoAdventHealth Translational Research Institute
Study Central Contact
Contact: Recruitment Department, 407-303-7100, [email protected]
1 Study Locations in 1 Countries

Florida

AdventHealth Translational Research Institute, Orlando, Florida, 32804, United States
Recruitment Department, Contact, 407-303-7100, [email protected]
Recruiting