Polycystic Ovary Syndrome | Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Polycystic Ovary Syndrome research study
What is the primary objective of this study?
The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets.
Who is eligible to participate?
Inclusion Criteria: - Body mass index (BMI) greater than or equal to 25 - Polycystic Ovary Syndrome criteria of both oligomenorrhea (<9 menses per year) and androgen excess [clinical hirsutism (Ferriman-Gallway score >8 or severe acne) or elevated testosterone]. - Taking no medications for the treatment of insulin resistance. Exclusion Criteria: - Diagnosis of Cushing's syndrome - Untreated hypo/hyperthyroidism - Elevated prolactin - Congenital adrenal hyperplasia - Renal insufficiency (creatinine > 1.5) - Diabetes - Medications that can significantly affect endothelial function - Pregnancy - Breast Feeding - Taking oral contraceptives - Currently smoking
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Polycystic Ovary Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MetforminApproximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MetforminMetformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
Delayed Start MetforminAfter baseline study visit, this arm will return after three months without metformin for a repeat of the baseline study visit prior to initiating metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
Start Date: March 2014
Completed Date: November 20, 2016
Phase: Phase 1
Primary Outcome: Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy
Secondary Outcome: Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy
Study sponsors, principal investigator, and references
Principal Investigator: Alice Chang, MD
Lead Sponsor: Mayo Clinic
Collaborator: St. Jude Medical