Pediatric Obesity Observational Prospective Trial

Completed

Conditions studied: Pediatric Obesity

In brief

Using an observational case-control cohort design, the investigator aims to define the mechanisms underlying microbiome regulation of metabolism in adolescence before and after medically indicated therapies for obesity. The investigator's overarching hypothesis is that gut bacteria control host weight, insulin sensitivity, and response to weight-loss treatments by modifying host metabolism.

Key facts

Study ID

NCT03139877

Run by

Duke University

People needed

295

Starts

2016-09-13

Expected to finish

2020-01-07

Last updated by the study team

2021-06-18

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Child aged 10-18 years
• Sexual Maturity Rating 2 or above (pubertal)
• Age- and gender-specific BMI ≥ 95th percentile
• Expected enrollment in Healthy Lifestyles Clinical Program > 6 months

You may not qualify if…

• Antibiotic use in the 1 month prior to expected enrollment
• Anticipated antibiotic use during the course of the study.
• Immunodeficiency or prior transplantation
• Type 1 diabetes mellitus
• Inborn error of metabolism
• No fluency in English or Spanish
• Identifiable cause of obesity including hypothyroidism, Cushing syndrome, known genetic obesity syndrome including melanocortin receptor 4 mutation, drug-induced obesity including steroids or anti-psychotics
• Significant medical or mental health condition that precludes treatment
• Receiving insulin
• Plans to move away from area in next 6 months
• Weight loss of >5% total body weight in prior 3 months
• Pregnancy (self-report, confirm with noted last menstrual period in chart)
• Home outside of a 50 mile radius from the HL Clinic.

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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