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Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans | Clinical Trials | Clareo Health

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

NCT02459106•AdventHealth Translational Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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
+5 more criteria

Locations (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, United States

Key Dates

Start Date

May 27, 2015

Primary Completion Date

January 24, 2017

Completion Date

December 19, 2024

Last Updated

March 7, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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