CompletedNot Applicable

Immunometabolism in Pediatric Obesity

United States82 participantsStarted 2019-04-25

Plain-language summary

This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Having an infection (viral, respiratory, gastrointestinal) in the previous 4 weeks * 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 * Taking any of the following medications that can affec…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

circulating CD4+T cells in Overweight/Obese vs Lean

Timeframe: After completion of all study visits, approximately 2 years.

circulating CD4+T cells in Type 2 Diabetic pre/post Metformin

Timeframe: After completion of all study visits, approximately 2 years.

Trial details

NCT IDNCT03960333

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-02-05

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.