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Trial NCT07102797

ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

Phase
Not given
Sponsor
Massachusetts General Hospital
Conditions
PCOS (Polycystic Ovary Syndrome); Puberty; Insulin Resistance; Physical Activity
Ages
8+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Caregiver: Caregiver of child (ie mother, father, or other legal guardian), English-speaking, Access to a device where they are able to receive study e-mails or textsLanguage * Child: English-speaking, Female, ages 8-12 years old at time of enrollmentAge, Pre-menarchal at time of baseline visit, at risk for Polycystic Ovary Syndrome (PCOS)/insulin resistance, as defined by (1) History of maternal PCOS/maternal GDM, (2) BMI >/= 85th percentileBMI, (3) History of premature adrenarche, or (4) Small (<10th %ile) for gestational age Exclusion Criteria (Child): * Medications at time of enrollment: Metformin, GLP-1R Agonist, Insulin, GnRH agonist * Endocrine conditions that would impact either insulin sensitivity, androgen concentrations, or growth * Insulin dynamics: Type 1 diabetes, Type 2 diabetes, Congenital HyperinsulinismDiabetes * Androgen Conditions: Adrenal tumor, Congenital Adrenal Hyperplasia * Hyperthyroidism or uncontrolled hypothyroidism (TSH >7.0 mIU/mL) * Growth Hormone Deficiency * Medical conditions that would impact PA participation: Type 1 diabetes; Cardiovascular, neurologic, and/or musculoskeletal conditions limiting ability to participate in physical activity. * Other medical comorbidities that would limit generalizability of findings, including: Severe congenital heart disease, Congenital anomalies, Cystic fibrosis, Cerebral palsy, Condition requiring use of nasogastric, gastric tube, or other alternative method of feeding, Undiagnosed conditions with significant impact on child's growth and development; Significant cardiac, hepatic, oncologic, inflammatory, or psychiatric disease.Cardiac · Hepatic

Restrictions found (6)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Somerville, Middlesex County