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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02700698
Other study ID # 205139
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date May 1, 2018

Study information

Verified date October 2021
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date May 1, 2018
Est. primary completion date April 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Arkansas Children's Nutrition Center Little Rock Arkansas
United States UAMS Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rose S, Carvalho E, Diaz EC, Cotter M, Bennuri SC, Azhar G, Frye RE, Adams SH, Børsheim E. A comparative study of mitochondrial respiration in circulating blood cells and skeletal muscle fibers in women. Am J Physiol Endocrinol Metab. 2019 Sep 1;317(3):E5 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women 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.
During the visit, approximately 0.5 days
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