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

Type 2 Diabetes Mellitus Clinical Trial

— miRNA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02459106
• Other study ID #: TRIMDFH 729828
• Status: Active, not recruiting
• Start date: May 27, 2015
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: January 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of miRNA will be measured as well as the adipose tissue specific miRNA.	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

External Links

•   Translational Research Institute for Metabolism and Diabetes