Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)

NCT ID: NCT02086526

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-11-20

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).

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Metformin

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.

Delayed Start Metformin

After 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.

Group Type: OTHER

Metformin

Intervention Type: DRUG

Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.

Interventions

Metformin

Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.

Intervention Type: DRUG

Other Intervention Names

Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Alice Y Chang

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alice Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31806099 (View on PubMed)

Other Identifiers

UL1TR000135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-000692

Identifier Type: -

Identifier Source: org_study_id