EFFECT OF LIFESTYLE INTERVENTION & METFORMIN IN POLYCYSTIC OVARY SYNDROME

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. We propose to build on the landmark findings of the Diabetes Prevention Program (1), where both lifestyle interventions and metformin therapy as single agent therapies significantly reduced the diabetes conversion rates in a high risk population and examine the effects of combination therapy compared to single agent therapy in women with PCOS. Specifically we hypothesize that combination therapy with lifestyle intervention and metformin will be more effective than lifestyle intervention and placebo in improving the stigmata of polycystic ovary syndrome. We propose to conduct two parallel trials of this hypothesis: Study 1: A 6-month randomized trial of lifestyle interventions with metformin compared to lifestyle interventions with placebo in adult females (Age 21-39) with PCOS. 1) Primary Outcome: We hypothesize that combination therapy will result in a greater improvement in ovulatory frequency. 2) Secondary Outcomes: We hypothesize that combination therapy will result in a greater improvement in circulating hyperandrogenemia and insulin sensitivity that single agent therapy. Study 2: A 6-month randomized trial of lifestyle interventions with metformin compared to lifestyle interventions with placebo in adolescent females (Ages 14-18) with PCOS. 1) Primary Outcome: We hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia than single agent therapy 2) Secondary Outcomes: We hypothesize that combination therapy will result in a greater improvement in ovulatory frequency and insulin sensitivity than single agent therapy.