Clinical Trials

Inclusion Criteria:

• Patients who are or will be included in POWER registry.
• Patients aged 6 to 26 years at time of recruitment for the current study.
• Patients who satisfy the criteria for early-onset obesity:
  • Criteria to identify early-onset obesity among patients aged 6 to 26 years will be consistent with the criteria used for the Uncovering Rare Obesity® Program, as follows:
    • For patients aged 6 to 18 years at study recruitment::
    • The patient’s body mass index (BMI) is ≥ 97th percentile at recruitment based on the Centers for Disease Control (CDC) charts, and;
    • The patient has early-onset obesity.
    • Early-onset obesity will be determined based on historical records of weight, height, age, and gender in the electronic medical record or patient chart using the following definitions:
    • Historical measurements from age < 2 years: sex-specific weight for recumbent length is ≥ 97.7th percentile on the World Health Organization (WHO) charts.
    • Historical measurements from age 2-5 years: BMI ≥97th percentile based on the CDC charts.
    • Only patients with verified weight and height information before the age of 6 years and who meet the criteria of early-onset obesity will be included in the study. For new patients without available measurements to confirm early-onset obesity (electronic medical record, patient chart and/or POWER data), at least 1 weight and height measurement prior to the age of 6 years will be obtained by the study investigator at each participating site (either from the electronic medical record or from the patient’s primary care provider).
    • For patients aged ≥ 18 years at study recruitment:
    • The patient’s BMI is ≥ 40 kg/m^2 at recruitment AND
    • The patient has early-onset obesity (as defined above), as documented in the electronic medical record or patient chart.

Exclusion Criteria: 

• Patients with prior testing for variants in the 36 genes of interest.
• Patients who have any of the following potential causes of secondary obesity:
  • Endocrine diagnoses (e.g., hypothyroidism, Cushing syndrome, growth hormone [GH] deficiency);
  • Neurologic diagnoses.;
  • Intracranial injury (including, but not limited to: tumor, trauma, surgery, pituitary resection, irradiation);
  • Hypothalamic obesity;
  • Medication-induced weight gain, as determined by the Investigator.

Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.