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CompletedNCT04126551Updated May 7, 2024

Mitochondrial Methylation in Type 2 Diabetes

An observational study in Overweight, Obesity and Diabetes Mellitus, Type 2, 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 2024-05-07.

Sponsored by University of Arizona · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
27
Ages
21 Years to 55 Years
Sex
All
01

Study summary

The overarching goal of this proposal is to determine whether DNA methylation of the mitochondrial DNA impairs mitochondrial function in insulin resistant states such as overweight/obesity and type 2 diabetes.

Read the detailed description

To determine whether differences in human skeletal muscle DNA methylation patterns in the mitochondrial and nuclear genome can explain the lower abundance of ETC and OXPHOS mRNA and protein observed in insulin resistant skeletal muscle of overweight/obese and type 2 diabetic participants. To determine whether patterns of human skeletal muscle DNA methylation in the mitochondrial and nuclear genome are predictive of ETC function. We will isolate skeletal muscle mitochondria from metabolically well-characterized lean insulin sensitive, overweight/obese insulin resistant nondiabetic and obese insulin resistant type 2 diabetic volunteers, and functionally evaluate each ETC complex (I - IV) and complex V (ATP synthase).

02

Conditions studied

  • Overweight
  • Obesity
  • Diabetes Mellitus, Type 2
  • Insulin Resistance
03

In context

Overweight

3,771 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 27 is below the median of 150 across 443 observational studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Arizona is the lead sponsor of 475 studies on the registry; 87 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.

Browse University of Arizona studies →

Counted across the registry records on this site, refreshed daily.

04

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) overweight/obese volunteers without type 2 diabetes, and 3) volunteers with type 2 diabetes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects must be 21-55 years old

  2. Body Mass Index:

    Lean, healthy BMI ≤25; Overweight,non-diabetic BMI 25-29.9; Obese, non-diabetic BMI 30-50; Type 2 Diabetes (per the American Diabetes Association criteria)

  3. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  4. Female subjects must be non-lactating and will be eligible only if they have a negative pregnancy test throughout the study period, and must agree to use acceptable birth control (hormonal contraceptives, barrier methods, have an intrauterine device, or surgical sterilization)

  5. Subjects must have the following laboratory values:

    • Hematocrit ≥ 35 vol%
    • Serum creatinine ≤ 1.6 mg/dl
    • AST (SGOT) \< 2 times upper limit of normal
    • ALT (SGPT) \< 2 times upper limit of normal
    • Alkaline phosphatase \< 2 times upper limit of normal
    • Triglycerides \< 150 mg/dl for nondiabetics
    • Triglycerides \<300 for diabetics
    • INR ≤ 1.3
    • HbA1c ≤ 10

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 must not be taking estrogens or other hormonal replacement therapy unless the subject has been on these agents on a stable dose for the prior three months. Subjects taking systemic glucocorticoids are excluded. Patients with type 2 diabetes will be excluded if they are taking thiazolidinediones.
  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>160, diastolic BP>95, autonomic neuropathy, resting heart rate >100, electrolyte abnormalities.
05

Study design

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

Groups and cohorts

  • Lean, healthy control

    Lean, healthy control subjects. Volunteers will be matched for sex and age 21-55 years old. Ethnicities studied will be self-reported. We will attempt to match on race/ethnicities with equal numbers of non-Hispanic/Latinos and Hispanics/Latinos.

    Other: Methylation status

  • Overweight/obese nondiabetic

    Overweight/Obese nondiabetic subjects. Overweight and obesity will be defined using the standard body mass index cutoffs. Volunteers will be matched for sex and age 21-55 years old. Ethnicities studied will be self-reported. We will attempt to match on race/ethnicities with equal numbers of non-Hispanic/Latinos and Hispanics/Latinos.

    Other: Methylation status

  • Type 2 diabetes

    Participants with type 2 diabetes will be diagnosed accordingly to ADA criteria. Volunteers will be matched for sex and age 21-55 years old. Ethnicities studied will be self-reported. We will attempt to match on race/ethnicities with equal numbers of non-Hispanic/Latinos and Hispanics/Latinos.

    Other: Methylation status

Interventions

  • OtherMethylation status

    Participants will be recruited, and muscle biopsies will be obtained for methylation analyses and measuring mitochondrial function

06

What researchers measure

Primary outcomes

  1. Mitochondrial DNA methylation

    Mitochondrial DNA methylation and D-loop of mitochondria is altered in insulin resistant states such as overweight/obesity and type 2 diabetes

    Time frame: 3 years

Secondary outcomes

  1. Mitochondrial Function

    The extent of mitochondrial function impairment in insulin resistant participants corresponds to the degree of methylation of the mitochondrial genome and D-loop

    Time frame: 3 years

07

Study locations

1 site
  • Clinical and Translational Research Center (CaTS)
    Tucson, Arizona 85724, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Dec 2023, 53 months.

Of 145 non-industry observational studies under Overweight, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 132. This study's 53 months is above that.

Counting every sponsor, half of 164 studies reached it within 38 months; a quarter within 15 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2019
First posted
Oct 15, 2019
StartActual
Jul 23, 2019
Primary completionActual
Dec 31, 2023
CompletionActual
Dec 31, 2023
Last update
May 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04126551
Lead sponsor
University of Arizona
Responsible party
Dawn K Coletta (Associate Professor of Medicine, University of Arizona) — Principal investigator
First posted
Oct 15, 2019
Start date
Jul 23, 2019
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
May 7, 2024

Study contacts

Dawn K Coletta, PhD
principal investigator · University of Arizona

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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