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Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans (miRNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02459106
Recruitment Status : Active, not recruiting
First Posted : June 1, 2015
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Brief Summary:
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.

Condition or disease
Type 2 Diabetes Mellitus

Detailed Description:

Study Objectives:

  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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans
Actual Study Start Date : May 27, 2015
Actual Primary Completion Date : January 24, 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort
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.
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.



Primary Outcome Measures :
  1. Levels of miRNA will be measured as well as the adipose tissue specific miRNA. [ Time Frame: 4 weeks ]
    The effect of miRNA released by adipose tissue from lean insulin-sensitive and from obese insulin-resistant individuals on skeletal muscle biology and insulin signaling.


Biospecimen Retention:   Samples With DNA
Muscle and adipose tissue biopsies will be obtained.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy obese insulin-resistant individuals Healthy lean insulin-sensitive individuals
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Lactation or pregnancy, current and/or within last 6 months, per participant's report
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459106


Locations
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United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Investigators
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Principal Investigator: Richard Pratley, MD Translational Research Institute for Metabolism and Diabetes
Additional Information:
Publications:

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Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT02459106    
Other Study ID Numbers: TRIMDFH 729828
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
micro-RNA
insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism