Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Last updated on April 2022Recruitment
- 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
- Elevated prolactin
- Diabetes
- Untreated hypo/hyperthyroidism
- ...
- Elevated prolactin
- Diabetes
- Untreated hypo/hyperthyroidism
- Congenital adrenal hyperplasia
- Diagnosis of Cushing's syndrome
- Breast Feeding
- Renal insufficiency (creatinine > 1.5)
- Medications that can significantly affect endothelial function
- Currently smoking
- Taking oral contraceptives
- Pregnancy
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
- Elevated prolactin
- Diabetes
- Untreated hypo/hyperthyroidism
- ...
- Elevated prolactin
- Diabetes
- Untreated hypo/hyperthyroidism
- Congenital adrenal hyperplasia
- Diagnosis of Cushing's syndrome
- Breast Feeding
- Renal insufficiency (creatinine > 1.5)
- Medications that can significantly affect endothelial function
- Currently smoking
- Taking oral contraceptives
- Pregnancy
Tracking Information
- NCT #
- NCT02086526
- Collaborators
- Abbott Medical Devices
- Investigators
- Principal Investigator: Alice Chang, MD Mayo Clinic
- Alice Chang, MD Mayo Clinic
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