HealthyMitoWomenNCT02700698
Mitochondrial Function in Circulating Cells and Muscle Tissue
An observational study of Healthy and Obesity, run by University of Arkansas at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Insulin Sensitivity
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to 1 May 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Twenty (20) healthy lean and 20 insulin resistant and obese women, age 25-35 years.
Who may be able to join
- Women
- 25-35 years of age
- Either healthy lean (BMI<25) or insulin resistant and obese (BMI >30)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
UAMS
Little Rock, Arkansas, 72202
About this study
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.
Read the 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.
- Conditions
- Healthy, Obesity, Insulin Sensitivity, Women
- Keywords
- Mitochondria, women, muscle, PBMC
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy lean | Healthy lean women, 25-35 years | |
| Overweight/obese with/without IR | Overweight/obese with/without insulin resistant women, 25-35 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the visit, approximately 0.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startSep 2016
- Primary completion26 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Elisabet Borsheim, PhD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700698
- Sponsor's protocol ID
- 205139
- Acronym
- MitoWomen
- Status last verified
- Oct 2021
- First submitted
- 16 Feb 2016
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rose S, Carvalho E, Diaz EC, Cotter M, Bennuri SC, Azhar G, Frye RE, Adams SH, Borsheim 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):E503-E512. doi: 10.1152/ajpendo.00084.2019. Epub 2019 Jun 18.
PubMed 31211617
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Function in Circulating Cells and Muscle Tissue
- ClinicalTrials.gov ID
- NCT02700698
- Acronym / sponsor ID
- MitoWomen / 205139
- Conditions
- Healthy, Obesity, Insulin Sensitivity, Women
- Keywords
- Mitochondria, women, muscle, PBMC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Study start
- Sep 2016
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy lean | – | –Healthy lean women, 25-35 years |
| Overweight/obese with/without IR | – | –Overweight/obese with/without insulin resistant women, 25-35 years |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty (20) healthy lean and 20 insulin resistant and obese women, age 25-35 years.
Key inclusion criteria (3 listed)
- Women
- 25-35 years of age
- Either healthy lean (BMI<25) or insulin resistant and obese (BMI >30)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31211617Rose S, Carvalho E, Diaz EC, Cotter M, Bennuri SC, Azhar G, Frye RE, Adams SH, Borsheim 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):E503-E512. doi: 10.1152/ajpendo.00084.2019. Epub 2019 Jun 18.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabet Borsheim, PhD principal investigator
Arkansas Children's Nutrition Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Obesity, run by University of Arkansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women (time frame: During the visit, approximately 0.5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.