Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans
NCT ID: NCT02459106
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2015-05-27
2024-12-19
Brief Summary
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Detailed Description
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1. To establish and optimize the methodology for measuring adipose tissue miRNA release.
2. To establish and optimize the methodology for measuring the effect of adipose tissue-released miRNA on skeletal muscle biology and insulin sensitivity.
3. To profile adipose tissue-released miRNA in lean insulin-sensitive and obese insulin-resistant healthy individuals.
4. To examine the effects of adipose tissue-released miRNA from lean insulin-sensitive individuals and obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy lean insulin-sensitive individuals
This group will be studied by measuring the adipose tissue miRNA release, adipose tissue-released miRNA will be profiled, and these effects will be examined.
No interventions assigned to this group
Obese insulin-resistant individuals
This group will be studied by measuring the effect of adipose tissue-release miRNA on skeletal muscle biology and insulin sensitivity, adipose tissue-released miRNA will be profiled, and these effects will be examined on obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 18-65 years of age
* BMI of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects)
* Stable body weight (\< 3 kg change in the last 8 weeks)
* homeostatic model assessment (HOMA)-insulin resistance \<2.7 if lean; homeostatic model assessment (HOMA)-insulin resistance ≥2.7 if obese
Exclusion Criteria
* Female subjects postmenopausal
* Cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
* Liver disease (AST or ALT(alanine aminotransferase)\>2.5 times the upper limit of normal)
* Kidney disease (creatinine \>1.6 mg/dl)
* Anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women)
* Thyroid dysfunction (abnormal TSH)
* HbA1c ≥6.5%
* Uncontrolled hypertension (systolic BP\>160 mmHg, diastolic BP\>100 mmHg)
* History of coagulopathies
* History (within the last 5 years) or presence of malignancy, (skin cancers, with the exception of melanoma, may be acceptable)
* Current or history of drug abuse or alcohol abuse (\>2 drinks/day)
* Prior treatment (within last 3 months) with systemic glucocorticoids (\>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates
* History of HIV, active Hepatitis B or C, or Tuberculosis (participant reported)
* Smoke \> 5 cigarettes per day
18 Years
65 Years
ALL
Yes
Sponsors
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AdventHealth Translational Research Institute
OTHER
Responsible Party
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Principal Investigators
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Richard Pratley, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Research Institute for Metabolism and Diabetes
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Countries
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References
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Related Links
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Translational Research Institute for Metabolism and Diabetes
Other Identifiers
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TRIMDFH 729828
Identifier Type: -
Identifier Source: org_study_id
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