Epigenetics and the Origin of Muscle Insulin Resistance in Humans

Obesity Clinical Trial

Official title:

Epigenetics and the Origin of Muscle Insulin Resistance in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726491
• Other study ID #: 11-007028
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: January 11, 2018
• Start date: August 2012
• Est. completion date: November 21, 2016

Study information

• Verified date: January 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 21, 2016
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Volunteers must be:

• 21 - 55 years old

• must be non-lactating, non-pregnant

• not taking medications known to affect glucose or if taking them, on stable doses.

• free of significant heart or lung disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 in Obese
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation of genes in insulin resistance	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.	Baseline to visit 33 (approx 2 months)
Secondary	mRNA expression of genes	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.	Baseline to visit 33 approx 2 months