Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases

Exclusion Criteria

• •Volunteers will be excluded (and referred to non-experimental treatment programs) for the following reasons:
• •Presence of renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome), or pulmonary disorders (other than either asthma not requiring continuous medication or sleep apnea-related disorders);
• •Adolescent girls who are pregnant, who are currently nursing an infant, or who are having unprotected intercourse;
• •Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study;
• •Subjects who regularly use prescription medications unrelated to the complications of obesity. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication for at least 3 months prior to study entry may be eligible;
• •Recent use (within six months) of anorexiant medications for the purpose of weight reduction;
• •Inability to undergo MRI (e.g., volunteers with metal within their bodies including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices such as infusion pumps, nerve stimulators, bone growth stimulators, etc. that are contraindications).
• •For pilot study participants, hypersensitivity or allergy to methylene blue. Individuals with documented G6PD deficiency will be excluded.
• •Volunteers will be excluded for the following reasons:
• •1. Presence of past or present medical problems which would impair performance during the exercise tests;
• •2. Females who are pregnant, or who are currently nursing an infant;
• •3. Individuals who have, or whose parent or guardian has, current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or possibly hinder completion of the study;
• •4. Recent weight change of more than 3% of body weight in the past two months;
• •5. Recent use (within six months) of anorexiant medications for the purpose of weight reduction;
• •6. Physical impairments that would prevent completion of either the walk/run test or the cycle test.