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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT00195858
Eligibility Criteria:
Inclusion Criteria:
* Male or female;
* aged 14-18 years,
* Tanner stage IV or above,
* waist circumference ≥75th percentile for age/gender
* body mass index ≥95th percentile for age, and gender
* AND/OR ≥85th percentile for age/gender with any of:
* Fasting glucose ≥6.0 fasting,
* 2-hour plasma glucose 7.8-11 mmol/L after 75 G oral glucose,
* fasting triglycerides \> 1.7 mmol/L,
* fasting plasma insulin \>105 pmol/L,
* HDL-C\<0.9 mmol/L, LDL-C\>3.0 mmol/L,
* total cholesterol/HDL-C \>90th percentile,
* or first-degree relative with type 2 diabetes
Exclusion Criteria:
* Participation during the previous 4 months in a regular program of exercise or aerobic sports greater than 2 times per week for at least 20 minutes per session.
* Diabetes mellitus.
* Body weight over 159 kg, and/or BMI\>45 kg/m2, exceeding capacity of DEXA and CT machines.
* Use of any performance-enhancing medication.
* Use of any medication or herbal supplement that is likely to affect body composition, lipids or glucose metabolism.
* Significant weight change (increase of ≥10%, or decrease≥5% of body weight during the two months before enrollment).
* Uncontrolled hypertension: BP \>150 mm Hg systolic or \>95 mm Hg diastolic BP in sitting position.
* Activity restrictions due to disease: unstable cardiac or pulmonary disease, significant arthritis.
* Other illness judged by the patient or study physician to make participation in this study inadvisable.
* Unwillingness/lack of availability to attend exercise and/or nutrition sessions at scheduled times and locations.
* Significant cognitive deficit resulting in inability to understand or comply with instructions.
* Pregnancy at the start of the study, or intention to become pregnant in the next year.
* Inability to communicate in English or French.
* Unwillingness of subject and/or parent/guardian to sign informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
18 Years
Study:
NCT00195858
Study Brief:
Protocol Section:
NCT00195858