NCT02459106Completed
Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese individuals. This information will be important for our understanding of how the body's sugar metabolism is regulated and why people who are obese become insulin resistant and are more likely to develop type 2 diabetes.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 46 (actual)
- First submitted
- 22 May 2015
- Start date
- 27 May 2015
- Primary completion date
- 24 Jan 2017
- Lead sponsor
- AdventHealth Translational Research Institute
- Diseases
- Type 2 diabetes
- NCT number
- NCT02459106
What you commit to
- Study type: Observational
- Participants enrolled: 46
- From 27 May 2015 to the primary completion date, 24 Jan 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment (within last 3 months) with systemic glucocorticoids (\>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates
Other illness
- Cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
- 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)
- History of HIV, active Hepatitis B or C, or Tuberculosis (participant reported)
Lab values
- 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)
- HbA1c ≥6.5%
Other
- Lactation or pregnancy, current and/or within last 6 months, per participant's report
- Female subjects postmenopausal
- Thyroid dysfunction (abnormal TSH)
- Smoke \> 5 cigarettes per day
Who the study is looking for
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.