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CompletedNCT03259984Updated Oct 14, 2019

Epigenetics of Muscle Insulin Resistance

An observational study in Diabetes Mellitus, Type 2 and Obesity, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-14.

Sponsored by University of Arizona · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Ages
21 Years to 55 Years
Sex
All
01

Study 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.

Read the 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. The investigators 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Obesity
03

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Three groups of volunteers will be studied: 1) lean, healthy volunteers, 2) obese volunteers without type 2 diabetes, and 3) volunteers with type 2 diabetes

Inclusion criteria

  1. Age 21-55
  2. BMI: Lean, BMI less than or equal to 25; Obese, BMI between 30- 50; type 2 diabetic, BMI between 30- 50.
  3. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  4. Subjects may be of either sex with age as described in each protocol. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period.
  5. Subjects must range in age as described in each specific protocol.
  6. Subjects must have the following laboratory values:

    1. Hematocrit ≥ 35 vol%
    2. Serum creatinine ≤ 1.6 mg/dl
    3. AST (SGOT) \< 2 times upper limit of normal
    4. ALT (SGPT) \< 2 times upper limit of normal
    5. Alkaline phosphatase \< 2 times upper limit of normal
    6. Triglycerides \< 150 mg/dl for nondiabetics
    7. Triglycerides \<300 for diabetics
    8. INR ≤ 1.3

Exclusion criteria

Exclusion Criteria

  1. Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded. Patients with type 2 diabetes will be excluded if they are taking thiazolidinediones, but may be taking sulfonylureas or other medications known to work through effects on insulin secretion.
  2. Subjects receiving Gemfibrozil must not also be receiving a statin.
  3. Subjects with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
  4. Recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic BP>180, diastolic BP>105, autonomic neuropathy, resting heart rate >100, electrolyte abnormalities.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Aim 1

    This experiment will use the next generation sequencing reduced representation bisulfite sequencing to 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. The investigators will test the hypotheses that: (a) 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, (b) The altered methylation patterns observed correspond to protein and mRNA expression changes, and (c) There are coordinated patterns of DNA methylation between the skeletal muscle and whole blood tissues in insulin resistance.

  • Aim 2

    This experiment will test the hypotheses in lean healthy, obese non-diabetic and type 2 diabetic volunteers that: (a) Increased methylation of the PGC-1α promoter predicts a decreased response of this gene to a single bout of exercise, and (b) Altered methylation of promoters of nuclear encoded mitochondrial genes predicts a decreased response of this gene to a single bout of exercise.

  • Aim 3

    This experiment will test the hypothesis in lean healthy, obese non-diabetic and type 2 diabetic volunteers that: (a) There is decreased methylation of genes involved in mitochondrial biogenesis and oxidative phosphorylation, and the altered methylation corresponds to protein and mRNA (messenger ribonucleic acid) expression changes, (b) There is altered methylation of genes involved in inflammation and cytoskeletal structure.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 months

Secondary outcomes

  1. 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.

    Time frame: 9 months

06

Study locations

1 site
  • University of Arizona
    Tucson, Arizona 85724, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03259984
Lead sponsor
University of Arizona
Responsible party
Dawn K Coletta (Associate Professor of Medicine, University of Arizona) — Principal investigator
First posted
Aug 24, 2017
Start date
Nov 2016
Primary completion
Nov 2, 2018
Completion
Nov 2, 2018
Last update
Oct 14, 2019

Study contacts

Dawn K Coletta, Ph.D.
principal investigator · University of Arizona

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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