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

AdventHealth Translational Research Institute1 site in 1 country12 target enrollmentMarch 30, 2021

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: AdventHealth Translational Research Institute
Enrollment: 12
Locations: 1
Primary Endpoint: Individual steps of muscle glucose uptake (pre-exercise)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 30, 2021

End Date

August 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AdventHealth Translational Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 30-65 years
•Men and women
•Body mass index (BMI) between 25 and 45 kg/m2
•Sedentary (1 day or less per week of structured exercise)
•Type 2 diabetes mellitus determined by self-report or by a fasting glucose \>126mg/dl
•Weight stable (± 2 kg) for prior 3 months
•Willing to commit to the schedule of assessment visits, including the exercise intervention

Exclusion Criteria

•Currently taking insulin, injectable incretin mimetics and thiazolidinediones
•Taking more than two glucose-lowering medications
•Resting blood pressure ≥ 160/100 mm Hg
•Triglycerides ≥ 500 mg/dL
•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
•Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)
•Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise training
•Pulse check ("Allen test") indicates participant has poor blood flow in the hands
•Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)
•Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year

Outcomes

Primary Outcomes

Individual steps of muscle glucose uptake (pre-exercise)

Time Frame: 24 hours

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.

Individual steps of muscle glucose uptake (post-exercise)

Time Frame: 24 hours

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.