NCT02086526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2016

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

2.7 years

First QC Date

March 11, 2014

Last Update Submit

March 15, 2018

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3 months

Secondary Outcomes (1)

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

    baseline, 3 months

Other Outcomes (2)

  • Change in Weight

    baseline, 3 months

  • Change in Testosterone

    baseline, 3 months

Study Arms (2)

Metformin

EXPERIMENTAL

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.

Drug: Metformin

Delayed Start Metformin

OTHER

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.

Drug: Metformin

Interventions

MetforminDRUG

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

Also known as: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet
Delayed Start MetforminMetformin

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 31806099DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Alice Chang, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

March 1, 2014

Primary Completion

November 20, 2016

Study Completion

November 20, 2016

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

US(1)