Investigating how exercise affects insulin resistance in Type 2 Diabetes
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
This study is testing how different types of exercise can help people with Type 2 Diabetes improve their insulin resistance and overall metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | AdventHealth Translational Research Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT04754581 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to explore the impact of exercise training on insulin resistance in skeletal muscle and adipose tissue among individuals with Type 2 Diabetes. Participants will undergo various assessments, including maximal ATP production tests, exercise testing, and biopsies of muscle and adipose tissue. The study will utilize a hyperinsulinemic euglycemic clamp to measure insulin sensitivity and mitochondrial energetics. The findings could provide insights into how exercise can improve metabolic health in this population.
Who should consider this trial
Good fit: Ideal candidates are sedentary adults aged 30-65 with a BMI between 25 and 45 who have Type 2 Diabetes.
Not a fit: Patients currently taking insulin or multiple glucose-lowering medications, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise recommendations for managing Type 2 Diabetes and enhancing metabolic health.
How similar studies have performed: Other studies have shown promising results in understanding the effects of exercise on insulin resistance, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Where this trial is running
Orlando, Florida
- AdventHealth Translational Research Institute — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Bret Goodpaster, PhD — Scientific Director | Senior Investigator
- Study coordinator: Recruitment Department
- Email: Fh.tri.recruitment@adventhealth.com
- Phone: 407-303-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.