NCT03960333Completed
Immunometabolism in Pediatric Obesity
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 82 (actual)
- First submitted
- 6 May 2019
- Start date
- 25 Apr 2019
- Primary completion date
- 5 Feb 2021
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT03960333
What you commit to
- Study type: Observational
- Participants enrolled: 82
- From 25 Apr 2019 to the primary completion date, 5 Feb 2021
- 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
- Having an infection (viral, respiratory, gastrointestinal) in the previous 4 weeks
- 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
- Taking metformin prescribed as part of their clinical care for longer than 3 weeks at the time of enrollment (may begin metformin therapy prescribed as part of their clinical care while enrolled in the study)
Other illness
- Genetic or physical conditions impacting mobility over past year as determined by the 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 CDC growth charts)
Other
- Subjects determined ineligible by the PI or delegated staff.
Who the study is looking for
- Age 5-17 years, inclusive
- Either healthy lean (BMI≥ 5th percentile and \<85th percentile for age/sex) or overweight (BMI ≥ 85th percentile and \<95th) or obese (BMI ≥ 95th percentile for age/sex)
- For those with BMI≥ 85th percentile for age/sex, parental verbal confirmation that the child had a history of BMI≥ 85th percentile for age/sex for at least six months prior to study enrollment OR
- Age 5 years - 17 years 5 months, inclusive
- Either overweight or obese (BMI≥ 85th percentile for age/sex)
- Parental verbal confirmation that the child had a history of BMI≥ 85th percentile for age/sex for at least six months prior to study enrollment
- Diagnosed with type 2 diabetes mellitus or insulin resistance
- Prescribed metformin (either not yet taking or began taking within 3 weeks of enrollment)
Age in the registry: 5 years to 17 years · Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arkansas Children's Research Institute Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.