Status:
COMPLETED
Bioenergetics and Metabolism in Pediatric Populations
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
5-17 years
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...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
October 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03323294
Start Date
October 18 2017
End Date
June 30 2024
Last Update
February 13 2025
Active Locations (1)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202