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Completed

NCT Number: NCT02700698

Mitochondrial Function in Circulating Cells and Muscle Tissue

The main goal of this project is to determine whether mitochondrial function in circulating cells is related to that measured in the muscle fibers of the same subjects.

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Key information

Conditions

Healthy Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Women

Age range

25 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Arkansas Children's Nutrition Center, Little Rock, Arkansas, United States

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About this study

Data from human and animal models strongly suggests that reduced tissue mitochondrial function can be an early marker for detection of dysfunctional metabolism. It is unclear if tissue mitochondrial dysfunction can be detected using less invasive methodology. In this project, the investigators plan to study mitochondrial bioenergetics in circulating cells and paired muscle biopsies in two metabolic disparate groups of women; healthy lean vs. overweight/obese with/without insulin resistant women of similar age. Women of similar age that are either healthy lean or overweight/obese with/without insulin resistance will be recruited to participate in one study that includes a blood draw and a muscle biopsy. Mitochondrial function in circulating blood cells and muscle tissue will be determined. The association between circulating blood cells and muscle tissue mitochondria respiration will be determined for the two groups combined, and differences between groups will also be investigated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women
  • 25-35 years of age
  • Either healthy lean (BMI<25) or insulin resistant and obese (BMI >30)

Exclusion criteria

  • Medication that can affect study outcomes, as determined by the principal investigator, including anti-diabetic medication
  • Chronic diseases, acute inflammation, chronic renal failure (glomerular filtration rate <45), or heart problems

Treatment and study plan

Primary outcomes

  1. Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women

    Time frame: During the visit, approximately 0.5 days

    Skeletal muscle (m.vastus lateralis) and peripheral blood mononuclear cell (PBMC) mitochondrial respiration were determined in response to substrate inhibitor coupling protocols using high resolution respirometry.

    From this, mitochondrial respiration in leak and coupled states, and reserve respiratory capacity were determined in mitochondria from skeletal muscle and from PBMCs. It was determined whether mitochondrial function in circulating cells is related to that measured in the muscle tissue of the same subjects.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Arkansas Children's Hospital Research Institute

Registry information

Acronym: MitoWomen

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2016
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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