Clinical trial: Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors (PowerUp) (NCT00477477)

Eligibility criteria:
Inclusion Criteria:

          -  Ages 8 to 17 years old

          -  Overweight, defined as BMI ≥ 85th%tile for age and gender

          -  At least two CV risk factor typical of the metabolic syndrome including insulin
             resistance, high or borderline blood pressure, low HDL, high TG

          -  Insulin > 10 u/L

          -  Able to attend study visits once a week at participant's home, and eat meals provided
             by the Children's Hospital CTSA Boston MA as supplied for most meals and snacks

          -  Non-smoker

          -  Able to understand/speak English

          -  Informed consent to participate from a parent or legal guardian. Adolescents must also
             provide written assent to participate in the study.

        Exclusion Criteria:

          -  Pre-existing physician diagnosis of a major medical illness or history of a major
             medical illness including but not limited to heart, kidney or liver disease, cancer,
             endocrinopathy including thyroid disorder, genetic syndrome or psychiatric illness,
             also including vasculitides such as Kawasaki disease or rheumatologic disorder;
             diabetes type I or II, evidence of severe fatty liver, hypertension requiring
             pharmacologic treatment, history of or current diagnosis of an major eating disorder

          -  Current or anticipated pregnancy

          -  Weight more than 275 lbs (125 kg)

          -  Abnormalities on initial screening assessment requiring pharmacotherapy urgent
             treatment, such as familial hyperlipidemia, end organ effects of hypertension, or
             metabolic abnormalities such as diabetes

          -  Taking any prescription medication or non-prescription substance that affects
             cholesterol levels, blood pressure, or insulin sensitivity (including but not limited
             to oral glucocorticoids, oral contraceptives, neuropsychiatric agents,
             anti-epileptics, HMG-CoA reductase inhibitors, bile acid binding cholesterol transport
             inhibitors among others) and the use of alcohol or illicit substances.

          -  Anticipated difficulty with participatory requirements of the study including food
             allergies, significantly restricted food preferences, or other difficulties as
             assessed by research staff.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 17 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Contradiction