Status:
RECRUITING
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
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-65 years
Phase:
NA
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).
Eligibility Criteria
Inclusion
- 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
- 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
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
- Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
- 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.
- New onset (\<3 months on a stable regime) hormone replacement therapy
- Current use of beta-adrenergic blocking agents
- Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- Increased liver function tests (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- Abnormal blood count/anemia, blood transfusion or blood donation within the last 2 months
- Current smokers (smoking within the past 3 months prior to screening visit, including any/all tobacco products)
- Current drug or alcohol abuse/dependence
- Metal implants (pace-maker, aneurysm clips) based on investigator's judgment at screening
- Not physically capable of performing the exercise required of the study protocols
- Plans to be away \>2 weeks in the next 3 months
- 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.
- Unable to tolerate MRI or claustrophobia.
- Nickel allergy
- Lidocaine allergy
- Unable or unwilling to communicate with staff or to provide written informed consent
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04754581
Start Date
March 30 2021
End Date
June 1 2025
Last Update
September 27 2024
Active Locations (1)
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1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804