Clinical trial NCT02086526: Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Official title: Targeting Pathophysiologic Pathways in Polycystic Ovary Syndrome Using a Response to Metformin Phenotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2014-03-13
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The investigators propose to use both targeted and non-targeted metabolomic approaches to identify pathways associated with metformin's effect on insulin sensitivity, weight, androgens and endothelial function. This project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets. This pilot project is intended to inform the development of hypothesis and specific aims for a future grant application to National Institutes of Health (NIH).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy
timeFrame: baseline, 3 months
Other outcomes:
measure: Change in Weight
timeFrame: baseline, 3 months
measure: Change in Testosterone
timeFrame: baseline, 3 months
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alice Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heidari B, Lerman A, Lalia AZ, Lerman LO, Chang AY. Effect of Metformin on Microvascular Endothelial Function in Polycystic Ovary Syndrome. Mayo Clin Proc. 2019 Dec;94(12):2455-2466. doi: 10.1016/j.mayocp.2019.06.015.