Epigenetics and the Origin of Muscle Insulin Resistance in Humans
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ClinicalTrials.gov Identifier: NCT01726491 |
Recruitment Status
:
Completed
First Posted
: November 15, 2012
Last Update Posted
: January 16, 2018
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Condition or disease |
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Diabetes Mellitus Type 2 in Obese Obesity |
Study Type : | Observational |
Actual Enrollment : | 46 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Epigenetics and the Origin of Muscle Insulin Resistance in Humans |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | November 21, 2016 |
Actual Study Completion Date : | November 21, 2016 |

Group/Cohort |
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Insulin resistance epigenetics
This experiment will use the Infinium methylation assay to perform epigenome mapping and define patterns of DNA methylation in skeletal muscle and whole blood tissue of metabolically well-characterized lean healthy, obese nondiabetic, and type 2 diabetic volunteers. We will test the hypotheses that (1) There is an increased methylation of genes involved in mitochondrial biogenesis and oxidative phosphorylation and altered methylation of promoters of genes coding for extracellular matrix and cytoskeletal proteins in insulin resistance, (2) The altered methylation patterns observed correspond to protein and mRNA expression changes, and (3) There are coordinated patterns of DNA methylation between the skeletal muscle and whole blood tissues in insulin resistance. |
Single bout of exercise
This experiment will test the hypotheses in lean healthy, obese non-diabetic and type 2 diabetic volunteers that
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Eight weeks of exercise
This experiment will test the hypothesis in lean healthy, obese non-diabetic and type 2 diabetic volunteers that
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- DNA methylation of genes in insulin resistance [ Time Frame: 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.
- mRNA expression of genes [ Time Frame: 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726491
United States, Arizona | |
Mayo Clinic in Arizona | |
Scottsdale, Arizona, United States, 85259 |
Principal Investigator: | Lori Roust, MD | Mayo Clinic | |
Principal Investigator: | Dawn K Coletta, Ph.D. | Mayo Clinic |
Responsible Party: | Lori R. Roust, Consultant in Endocrinology, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01726491 History of Changes |
Other Study ID Numbers: |
11-007028 |
First Posted: | November 15, 2012 Key Record Dates |
Last Update Posted: | January 16, 2018 |
Last Verified: | January 2018 |
Keywords provided by Lori R. Roust, Mayo Clinic:
Insulin resistance Exercise Type 2 diabetes mellitus Obesity Epigenetic studies |
Additional relevant MeSH terms:
Diabetes Mellitus Insulin Resistance Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hyperinsulinism Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |