Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criteria

Taking no medications for the treatment of insulin resistance.
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].
Body mass index (BMI) greater than or equal to 25
Taking no medications for the treatment of insulin resistance.
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].
Body mass index (BMI) greater than or equal to 25

Exclusion Criteria

Diabetes
Congenital adrenal hyperplasia
Taking oral contraceptives
...
Diabetes
Congenital adrenal hyperplasia
Taking oral contraceptives
Untreated hypo/hyperthyroidism
Diagnosis of Cushing's syndrome
Breast Feeding
Renal insufficiency (creatinine > 1.5)
Pregnancy
Medications that can significantly affect endothelial function
Currently smoking
Elevated prolactin

Summary

Conditions
Polycystic Ovary Syndrome
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only females

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 Pol...

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).

Inclusion Criteria

Taking no medications for the treatment of insulin resistance.
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].
Body mass index (BMI) greater than or equal to 25
Taking no medications for the treatment of insulin resistance.
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].
Body mass index (BMI) greater than or equal to 25

Exclusion Criteria

Diabetes
Congenital adrenal hyperplasia
Taking oral contraceptives
...
Diabetes
Congenital adrenal hyperplasia
Taking oral contraceptives
Untreated hypo/hyperthyroidism
Diagnosis of Cushing's syndrome
Breast Feeding
Renal insufficiency (creatinine > 1.5)
Pregnancy
Medications that can significantly affect endothelial function
Currently smoking
Elevated prolactin

Tracking Information

NCT #
NCT02086526
Collaborators
Abbott Medical Devices
Investigators
  • Principal Investigator: Alice Chang, MD Mayo Clinic
  • Alice Chang, MD Mayo Clinic