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

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional basic science trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Metformin

Delayed Start Metformin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy

Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with the trapezoidal rule.

Secondary Outcome Measures

Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy

The ratio of Peripheral Digital Arterial Tonometry (PAT) signal after cuff release compared with baseline is calculated through a computer algorithm normalizing for baseline measurements and indexing to measurements in the contra-lateral arm. The calculated ratio reflects the reactive hyperemia index (RHI).

Full Information

NCT ID

NCT02086526

First Posted

March 11, 2014

Last Updated

March 15, 2018

Sponsor

Mayo Clinic

Collaborators

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT02086526

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

November 20, 2016 (Actual)

Study Completion Date

November 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Description

Arm Title

Delayed Start Metformin

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy

Description

Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with the trapezoidal rule.

Time Frame

Baseline, 3 months

Secondary Outcome Measure Information:

Title

Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy

Description

Time Frame

baseline, 3 months

Other Pre-specified Outcome Measures:

Title

Change in Weight

Time Frame

baseline, 3 months

Title

Change in Testosterone

Time Frame

baseline, 3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alice Chang, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31806099

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.

Results Reference

derived

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

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