Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus Type 2 in Obese Obesity

Keywords

Insulin resistanceExerciseType 2 diabetes mellitusObesityEpigenetic studies

Outcome Measures

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.
Baseline to visit 33 (approx 2 months)

Secondary Outcomes (1)

mRNA expression of genes
Baseline to visit 33 approx 2 months

Study Arms (3)

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 1. Increased methylation of the PGC-1α promoter predicts a decreased response of this gene to a single bout of exercise, and 2. Altered methylation of promoters of nuclear encoded mitochondrial genes predicts a decreased response of this gene to a single bout of exercise.

Eight weeks of exercise

This experiment will test the hypothesis in lean healthy, obese non-diabetic and type 2 diabetic volunteers that 1. 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, 2. There is altered methylation of genes involved in inflammation and cytoskeletal structure.

Eligibility Criteria

Age21 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Biospecimen

Retention: SAMPLES WITH DNA

thigh muscle biopsies bloodsamples

MeSH Terms

Conditions

ObesityInsulin ResistanceMotor ActivityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Study Officials

Lori Roust, MD
Mayo Clinic
PRINCIPAL INVESTIGATOR
Dawn K Coletta, Ph.D.
Mayo Clinic
PRINCIPAL INVESTIGATOR

Enrollment

46 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Consultant in Endocrinology

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 15, 2012

Study Start

August 2012

Date type not reported

This date has not been verified as actual or estimated.

Epigenetics and the Origin of Muscle Insulin Resistance in Humans

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Insulin resistance epigenetics

Single bout of exercise

Eight weeks of exercise

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Insulin resistance epigenetics

Single bout of exercise

Eight weeks of exercise

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations