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

February 5, 2024 updated by: AdventHealth Translational Research Institute
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy obese insulin-resistant individuals Healthy lean insulin-sensitive individuals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Richard Pratley, MD, Translational Research Institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

May 27, 2015

Primary Completion (Actual)

January 24, 2017

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimated)

June 1, 2015

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 729828

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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