Clinical trial: Immunometabolism in Pediatric Obesity (NCT03960333)

Eligibility criteria:
Inclusion Criteria:

          -  Age 5-17 years, inclusive

          -  Either healthy lean (BMI≥ 5th percentile and <85th percentile for age/sex) or
             overweight (BMI ≥ 85th percentile and <95th) or obese (BMI ≥ 95th percentile for
             age/sex)

          -  For those with BMI≥ 85th percentile for age/sex, parental verbal confirmation that the
             child had a history of BMI≥ 85th percentile for age/sex for at least six months prior
             to study enrollment OR

          -  Age 5 years - 17 years 5 months, inclusive

          -  Either overweight or obese (BMI≥ 85th percentile for age/sex)

          -  Parental verbal confirmation that the child had a history of BMI≥ 85th percentile for
             age/sex for at least six months prior to study enrollment

          -  Diagnosed with type 2 diabetes mellitus or insulin resistance

          -  Prescribed metformin (either not yet taking or began taking within 3 weeks of
             enrollment)

        Exclusion Criteria:

          -  Having an infection (viral, respiratory, gastrointestinal) in the previous 4 weeks

          -  Genetic or physical conditions impacting mobility over past year as determined by the
             PI

          -  Having known chronic illnesses/disorders that may independently affect study outcome
             measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental
             (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's),
             hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except
             well controlled asthma that does not require permanent use of inhaled/oral steroids

          -  Taking any of the following medications that can affect study outcome: antipsychotics,
             thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs
             (growth hormone replacement therapy and oxandrolone) and stimulants

          -  Taking metformin prescribed as part of their clinical care for longer than 3 weeks at
             the time of enrollment (may begin metformin therapy prescribed as part of their
             clinical care while enrolled in the study)

          -  BMI<5th percentile for age/sex (classified as underweight based on CDC growth charts)

          -  Subjects determined ineligible by the PI or delegated staff.
No condition on gender to be admitted to the trial.

Subject must be at least 5 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