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Bioenergetics and Metabolism in Pediatric Populations

Bioenergetics and Metabolism in Pediatric Populations

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03323294
Enrollment
79
Registered
2017-10-27
Start date
2017-10-18
Completion date
2024-06-30
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity, Type 2 Diabetes Mellitus

Keywords

Obesity, Pediatric Health, Type 2 Diabetes, Insulin Resistance, Metformin Therapy

Brief summary

The investigators want to learn more about obesity, the development of insulin resistance, and Type 2 Diabetes in children. The investigators will do this through collecting information about children's health and conducting experiments on a variety of samples.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Arkansas
CollaboratorOTHER
Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 5-9 years and Tanner stage as reported by parent no greater than stage 1 OR Age 5 years - 17 years 5 months, diagnosed with type 2 diabetes mellitus or insulin resistance * Either healthy lean (BMI≥ 5th percentile and \<85th percentile for age/sex) or obese (BMI ≥ 95th percentile for age/sex) * For those with BMI≥ 95th percentile for age/sex, parental verbal confirmation will be obtained that the child had a history of BMI≥ 95th percentile for age/sex for at least six months prior to study enrollment

Exclusion criteria

* Genetic or physical conditions impacting mobility over past year as determined by the Principal Investigator (PI) * Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids * Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants * BMI\<5th percentile for age/sex (classified as underweight based on Centers for Disease Control and Prevention growth charts) * Subjects determined ineligible by the PI.

Design outcomes

Primary

MeasureTime frameDescription
Altered circulating blood cell bioenergeticsAfter completion of all study visits, approximately 2 years.The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit altered circulating blood cell bioenergetics.
Oxidized plasma redox stateAfter completion of all study visits, approximately 2 years.The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit a more oxidized plasma redox state.
Alterations in resting energy expenditureAfter completion of all study visits, approximately 2 years.The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of decreased resting energy expenditure.
Alterations in fatty acid oxidationAfter completion of all study visits, approximately 2 years.We hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of impaired fatty acid oxidation (FAO).
Poor oxidative capacityAfter completion of all study visits, approximately 2 years.The investigators hypothesize that poor oxidative capacity over time may distinguish between metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) phenotypes.
Predicting Type 2 Diabetes developmentAfter completion of all study visits, approximately 2 years.The investigators hypothesize that poor oxidative capacity over time may be predictive of Type 2 Diabetes development.
Bioenergetics in Type 2 Diabetes with metformin6 monthsThe investigators hypothesize that the change in bioenergetics will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Resting Energy Expenditure in Type 2 Diabetes with metformin6 monthsThe investigators hypothesize that the change in resting energy expenditure will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
Fatty Acid Oxidation in Type 2 Diabetes with metformin6 monthsThe investigators hypothesize that the change in fatty acid oxidation will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026