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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-03-30

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04754581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Recruitment Department

CONTACT

407-303-7100

Fh.tri.recruitment@adventhealth.com

Principal Investigator

Bret Goodpaster, PhD

PRINCIPAL_INVESTIGATOR

Scientific Director | Senior Investigator

Study Locations (Sites)

AdventHealth Translational Research Institute

Orlando, Florida, 32804

United States

Collaborators and Investigators

Sponsor: AdventHealth Translational Research Institute

Bret Goodpaster, PhD, PRINCIPAL_INVESTIGATOR, Scientific Director | Senior Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-30

Study Completion Date2025-06

Study Record Updates

Study Start Date2021-03-30

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Type 2 Diabetes