Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02459106
NCT02459106CompletedNot Applicable

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

AdventHealth Translational Research Institute1 site in 1 country46 target enrollmentStarted: May 27, 2015Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
46
Locations
1
Primary Endpoint
Levels of miRNA will be measured as well as the adipose tissue specific miRNA.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
AdventHealth Translational Research Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
Biological Changes in the Adipose Tissue Among Pregnant Women With DiabetesPregnancyDiabetes
NCT02383537Hadassah Medical Organization150
Completed
Not Applicable
Training Effects on Skeletal Muscle Fatty Acid MetabolismHealthy Volunteers
NCT00786487University of Minnesota33
Withdrawn
Not Applicable
miRNA and Myokines in Patients With PAHPulmonary Arterial Hypertension
NCT03905083University of Pittsburgh
Terminated
Not Applicable
Mitochondrial Respiratory Function in Mammalian Skeletal MuscleCachexiaCancer
NCT02650570The University of Texas Medical Branch, Galveston1
Completed
Not Applicable
miRNA in Patients With Thoracic, Abdominal and Intracranial AneurysmsVascular Aneurysm
NCT05382611Na Homolce Hospital35