Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
The purpose of this study is to:
1) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus
rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal
hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.
OCPs are the first-line therapy for PCOS, however, they do not address the insulin
resistance or the inflammation. Insulin sensitizers have been used successfully to treat
PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents.
Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol
versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive
evaluations before and 6 months after randomization, to the respective treatment arms to
determine the differences between the 2 treatment modalities.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To compare the effects of 6 months of treatment with drospirenone/ethinyl estradiol versus rosiglitazone on insulin resistance.
Insulin resistance will be assessed by the hyperinsulinemic-euglycemic clamp. In addition glucose tolerance will be assessed using an oral glucose tolerance test
Silva Arslanian, M.D.
University of Pittsburgh
United States: Institutional Review Board
|Children's Hospital||Philadelphia, Pennsylvania|