Clinical Trial: Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess (CBS005)

Brief 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).

Detailed Summary:
Sponsor: University of Virginia

Current Primary Outcome: Changes in free testosterone or 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after metformin administration for 12 weeks [ Time Frame: 12 weeks after metformin administration ]

Original Primary Outcome: Changes in free testosterone or 17 OH progesterone levels after ACTH and r-hCG administration respectively, before and after metformin administration for 12 weeks [ Time Frame: 12 weeks after metformin administration ]

Current Secondary Outcome: Changes in adrenal and ovarian steroid precursors after ACTH and rhCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of metformin administration [ Time Frame: 12 weeks after metformin administration ]

Original Secondary Outcome: Changes in adrenal and ovarian steroid precursors after ACTH and r-hCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of metformin administration [ Time Frame: 12 weeks after metformin administration ]

Information By: University of Virginia

Dates:
Date Received: August 22, 2011
Date Started: December 2016
Date Completion: December 2019
Last Updated: December 16, 2016
Last Verified: December 2016