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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin
PhasePhase 1
SponsorMayo Clinic
Responsible PartyMayo Clinic
ClinicalTrials.gov IdentifierNCT02086526
First ReceivedMarch 11, 2014
Last UpdatedMarch 18, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateMarch 11, 2014
Last Updated DateMarch 18, 2014
Start DateMarch 2014
Estimated Primary Completion DateMarch 2016
Current Primary Outcome MeasuresChange in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy [Time Frame: Baseline, 3 months] [Designated as safety issue: Yes]Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with a the trapezoidal rule.
Current Secondary Outcome MeasuresChange in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy [Time Frame: baseline, 3 months] [Designated as safety issue: Yes]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).

Descriptive Information[ + expand ][ + ]

Brief TitleTargeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Official TitleTargeting Pathophysiologic Pathways in Polycystic Ovary Syndrome Using a Response to Metformin Phenotype
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).
Study TypeInterventional
Study PhasePhase 1
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
ConditionPolycystic Ovary Syndrome
InterventionDrug: 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.
Other Names:
Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet
Study Arm (s)Experimental: 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment150
Estimated Completion DateMarch 2016
Estimated Primary Completion DateMarch 2016
Eligibility Criteria
Inclusion:

- 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:

- 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT02086526
Other Study ID Numbers13-000692
Has Data Monitoring CommitteeNo
Information Provided ByMayo Clinic
Study SponsorMayo Clinic
CollaboratorsNot Provided
Investigators Principal Investigator: Alice Chang, MD Mayo Clinic
Verification DateMarch 2014

Locations[ + expand ][ + ]

Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Contact: Tammi R Johnson | 507-255-6940 | johnson.tammi@mayo.edu
Principal Investigator: Alice Y Chang, MD
Recruiting