Epigenetics and the Origin of Muscle Insulin Resistance in Humans

Completed

• Conditions: Obesity; Diabetes Mellitus Type 2 in Obese

• Registration Number: NCT01726491
• Lead Sponsor: Mayo Clinic

Brief Summary

The investigators are trying to understand the role of DNA (deoxyribonucleic acid) methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a normal chemical process in the body that modifies DNA. By studying this, the investigators hope to better understand the causes of insulin resistance.

Detailed Description

Insulin resistance is defined as the decreased ability of insulin to perform its biological function in the muscle, liver and fat. Genetic and environmental factors are known to influence insulin sensitivity. It is not known how this is mediated. This study looks at the role of epigenetics (modifications of proteins associated with DNA and methylation of DNA) in alterations in insulin resistance. We will study lean healthy people, obese non-diabetic people and people with type 2 diabetes to characterize the DNA methylation patterns in muscle in each group. The second aim of the study is to see how a single bout of exercise affects the DNA methylation in the muscle. The third aim looks at the effect of 8 weeks of supervised exercise on the DNA methylation.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-15
• Primary Completion: 2016-11-21
• Study Completion: 2016-11-21
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DNA methylation of genes in insulin resistance	Baseline to visit 33 (approx 2 months)	DNA methylation of genes involved in mitochondrial biogenesis, oxidative phosphorylation, extracellular matrix and cytoskeleton proteins in insulin resistance, with an acute episode of exercise, and with eight weeks of training exercise.

Secondary Outcome Measures

Name	Time	Method
mRNA expression of genes	Baseline to visit 33 approx 2 months	mRNA expression of genes involved in mitochondrial biogenesis, oxidative phosphorylation, extracellular matrix and cytoskeletal signaling are altered in insulin resistance, with an acute episode of exercise and with 8 weeks of exercise training.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States