Bioenergetics and Metabolism in Pediatric Populations

Completed

• Conditions: Obesity; Insulin Resistance; Type 2 Diabetes Mellitus

• Registration Number: NCT03323294
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-27
• Study Start: 2017-10-18
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-27
• Primary Completion: 2020-03-06
• Study Completion: 2024-06-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predicting Type 2 Diabetes development	After 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 metformin	6 months	The 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.
Alterations in resting energy expenditure	After 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.
Altered circulating blood cell bioenergetics	After 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 state	After 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 fatty acid oxidation	After 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).
Fatty Acid Oxidation in Type 2 Diabetes with metformin	6 months	The 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.
Poor oxidative capacity	After 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.
Resting Energy Expenditure in Type 2 Diabetes with metformin	6 months	The 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.

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States