MitoWomen: Mitochondrial Function in Circulating Cells and Muscle Tissue

Sponsor
University of Arkansas (Other)
Overall Status
Completed
CT.gov ID
NCT02700698
Collaborator
Arkansas Children's Hospital Research Institute (Other)
35
2
19.9
17.5
0.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Mitochondrial Function in Circulating Cells and Muscle Tissue
    Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    Apr 26, 2018
    Actual Study Completion Date :
    May 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy lean

    Healthy lean women, 25-35 years

    Overweight/obese with/without IR

    Overweight/obese with/without insulin resistant women, 25-35 years

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Children's Nutrition Center Little Rock Arkansas United States 72202
    2 UAMS Little Rock Arkansas United States 72202

    Sponsors and Collaborators

    • University of Arkansas
    • Arkansas Children's Hospital Research Institute

    Investigators

    • Principal Investigator: Elisabet Borsheim, PhD, Arkansas Children's Nutrition Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT02700698
    Other Study ID Numbers:
    • 205139
    First Posted:
    Mar 7, 2016
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by University of Arkansas
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Healthy Lean Overweight/Obese +/- IR
    Arm/Group Description Healthy lean women, 25-35 years Overweight/obese and/or insulin resistant women, 25-35 years
    Period Title: Overall Study
    STARTED 17 18
    COMPLETED 16 18
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Healthy Lean Overweight/Obese With/Without IR Total
    Arm/Group Description Healthy lean women, 25-35 years Overweight/obese with/without insulin resistant women, 25-35 years Total of all reporting groups
    Overall Participants 17 18 35
    Age, Customized (Count of Participants)
    25-35 years
    17
    100%
    18
    100%
    35
    100%
    Sex/Gender, Customized (Count of Participants)
    Female
    17
    100%
    18
    100%
    35
    100%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    4
    23.5%
    5
    27.8%
    9
    25.7%
    White
    13
    76.5%
    12
    66.7%
    25
    71.4%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    1
    5.6%
    1
    2.9%
    Region of Enrollment (participants) [Number]
    United States
    17
    100%
    18
    100%
    35
    100%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    22.4
    (1.4)
    35.6
    (7.0)
    29.2
    (8.4)

    Outcome Measures

    1. Primary Outcome
    Title Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women
    Description 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.
    Time Frame During the visit, approximately 0.5 days

    Outcome Measure Data

    Analysis Population Description
    Out of the 35 enrolled, 32 participants had all samples (paired blood and muscle samples). Thus, they were their own controls, and for the main question about correlation between circulating cells and muscle mitochondrial respiration, samples were all analyzed together. This enabled comparison of circulating cells/muscle mitochondria respiration along a spectrum of BMIs and insulin resistance.
    Arm/Group Title Healthy Lean Overweight/Obese +/- IR
    Arm/Group Description Healthy lean women, 25-35 years Overweight/obese and/or insulin resistant women, 25-35 years
    Measure Participants 16 16
    PBMC ATP linked respiration
    26.48
    (2.54)
    30.46
    (2.44)
    PBMC max respiration
    120.04
    (11.88)
    140.43
    (14.30)

    Adverse Events

    Time Frame Approximately 10 days following biopsy
    Adverse Event Reporting Description Cross-sectional study with no intervention. Moderate risk study with one blood sample and one muscle biopsy.
    Arm/Group Title Healthy Lean Overweight/Obese +/- IR
    Arm/Group Description Healthy lean women, 25-35 years Overweight/obese and/or insulin resistant women, 25-35 years
    All Cause Mortality
    Healthy Lean Overweight/Obese +/- IR
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/18 (0%)
    Serious Adverse Events
    Healthy Lean Overweight/Obese +/- IR
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/18 (0%)
    Other (Not Including Serious) Adverse Events
    Healthy Lean Overweight/Obese +/- IR
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/18 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Elisabet Borsheim, PhD
    Organization University of Arkansas for Medical Sciences; Arkansas Children's Research Institute
    Phone 501-364-3053
    Email EBorsheim@uams.edu
    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT02700698
    Other Study ID Numbers:
    • 205139
    First Posted:
    Mar 7, 2016
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Oct 1, 2021