Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT03137433
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
* 13-17 years old
Exclusion Criteria:
* Type 1 or 2 diabetes mellitus
* Previous (within 6 months) or current use of meal replacements
* Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)
* If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
* Previous bariatric surgery
* If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
* If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months
* History of treatment with growth hormone
* Neurodevelopmental disorder severe enough to impair ability to comply with study protocol
* Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse
* Females: currently pregnant or planning to become pregnant
* Tobacco use
* Bulimia nervosa
* Endorsement of vomiting, laxative use, and/or diuretic use for weight control (EDE-Q)
* Binge eating disorder
* Neurological disorder
* Hypothalamic obesity
* Obesity associated with genetic disorder (monogenetic obesity)
* Hyperthyroidism or uncontrolled hypothyroidism
* History of cholelithiasis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT03137433
Study Brief:
Protocol Section:
NCT03137433