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:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT02358928
Eligibility Criteria:
Inclusion Criteria:
1. Age 11 - 17 years
2. Male and Female subjects
3. BMI \>= 95th percentile according to CDC body mass index chart for age and gender
4. Must be willing to participate and undergo "willingness to change" evaluation
5. Metabolic Syndrome(MetS) which is defined when 3 of the following are met:
* Central adiposity (waist circumference ≥90th% for age and sex)
* Hypertriglyceridemia (triglycerides ≥ 110mg/dl)
* Low HDL cholesterol ≤40mg/dl
* Elevated blood pressure systolic or diastolic blood pressure \> 90th % adjusted for age, sex and height or ≥ 130/85
* IFG (Impaired fasting glucose ≥ 100mg/dl or elevated HOMA- IR ≥3.16)
6. ALT greater than 60 U/L and Non Alcoholic Fatty Liver Disease based on histologic confirmation on liver biopsy (minimum of 5% of hepatocytes with macrovesicular fat) obtained within 6 months before randomization
Exclusion Criteria:
1. Those patients with a history of poor compliance or adherence to energy restriction diets
2. Patients on medications that could alter appetite including glucocorticoids, psychostimulants (Vyvanse, Adderall), psychotropic medications (Zoloft, Risperdal), and antihyperglycemic medications (metformin, sulfonylurea)
3. Patients with the following illnesses:
* Type 2 diabetes
* Renal disease
* Mental diseases (mood, psychotic and anxiety disorders)
* Developmental delay
* Autism and autism spectrum disorders
* Any liver disease except for non alcoholic fatty liver (NAFLD)
* Metabolic disorders (tyrosinemia, glycogen storage disease, lysosomal disorders)
* Congenital heart disease
* Myopathies or muscular disorders/disability
4. Patients who follow a (cultural or religious) vegetarian lifestyle as this would not be compatible with Carbohydrate Restriction (need for high quality protein)
5. Prepubertal patients defined by a tanner stage of 1
6. Current or history of significant alcohol consumption
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
17 Years
Study:
NCT02358928
Study Brief:
Protocol Section:
NCT02358928