Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With A… (NCT01422746) | Clinical Trial Compass
UnknownEarly Phase 1
Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess
United States20 participantsStarted 2017-03-20
Plain-language summary
This study will test whether metformin administration can ameliorate androgen (male hormone) overproduction in overweight pubertal girls with androgen excess. The investigators hypothesize that improvement in insulin sensitivity by 12 weeks of metformin administration will improve androgen levels after adrenal stimulation testing with adrenocorticotropic hormone (ACTH) or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).
Who can participate
Age range7 Years – 18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Overweight(\>85th BMI%) females
* Early to late puberty (expected age range 7-18)
* Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
* Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Exclusion Criteria:
* Age \< 7 or \> 18 y
* Inability to comprehend what will be done during the study or why it will be done
* BMI-for-age \< 5th percentile
* Positive pregnancy test or lactation.
* Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error.
* Morning cortisol \< 3 µg/dL or history of Cushing syndrome or adrenal insufficiency
* History of congenital adrenal hyperplasia or 17-hydroxyprogesterone \> 300 ng/dL, which suggests the possibility of congenital adrenal hyperplasia (if postmenarcheal, the 17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40 days since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone \>300 mg/dL is confirmed on repeat testing, an ACTH-stimulated 17-hydroxyprogesterone \<1000 ng/dL will be required for study participation.
* Total testoste…
What they're measuring
1
Changes in free testosterone or 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after metformin administration for 12 weeks
Timeframe: 12 weeks after metformin administration