- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427462
Mitochondria (MI) Energy - Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children
December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children
This research study is about how daily activities, behaviors, and fitness affect the health and function of blood cells and their mitochondria, which are the powerhouses of the cells.
These small mitochondria inside the cells make energy, and are very important for the health of the body.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Determine the impact of physical activity and obesity status on circulating cells mitochondrial function (e.g., fat vs. carbohydrates combustion capacity, total oxidative capacity, mitochondrial number and proton leak).
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tonja C Nolen, MS
- Phone Number: 501-364-3309
- Email: acncstudies@archildrens.org
Study Contact Backup
- Name: Audrey Martinex, MS, RD, LD
- Phone Number: 501-364-3309
- Email: acncstudies@archildrens.org
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72203
- Recruiting
- Arkansas Children's Nutrition Center
-
Contact:
- Tonja Nolen, MS
- Phone Number: 501-364-2853
- Email: acncstudies@archildrens.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
8-10 year olds
Description
Inclusion Criteria:
Ages 8-10 years Boys and girls All ethnicity All BMI
Exclusion Criteria:
severe persistent asthma exercise induced asthma autism spectrum disorder attention deficit hyperactivity disorder attention deficit disorder
- Opposition defiant disorder
- conduct disorder
- epilepsy
- chronic kidney disease
- hormonal disease
- autoimmune diseases
- bleeding disorders
- chronic infections
- mental health disorder
- Type 2 and Type 1 diabetes
- Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old.
Time Frame: 8 days
|
Platelet mitochondrial respiration from isolated platelets will be measured using a flux analyzer.
Adiposity will be measured with dual X-ray absorptiometry, and peak aerobic capacity with an incremental cycle ergometer test.
measure physical activity
|
8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
April 10, 2020
First Submitted That Met QC Criteria
June 10, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Estimated)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 260376
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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