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NCT03323294Completed

Bioenergetics and Metabolism in Pediatric Populations

Source: ClinicalTrials.gov · Last updated 13 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
79 (actual)
First submitted
27 Sept 2017
Start date
18 Oct 2017
Primary completion date
6 Mar 2020
Lead sponsor
Arkansas Children's Hospital Research Institute
NCT number
NCT03323294

What you commit to

  • Study type: Observational
  • Participants enrolled: 79
  • From 18 Oct 2017 to the primary completion date, 6 Mar 2020
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Age

  • BMI\<5th percentile for age/sex (classified as underweight based on Centers for Disease Control and Prevention growth charts)

Other

  • Subjects determined ineligible by the PI.

Who the study is looking for

  • 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

Age in the registry: 5 years to 17 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Arkansas Children's Hospital
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.