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. |
---|---|
Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin |
Phase | Phase 1 |
Sponsor | Mayo Clinic |
Responsible Party | Mayo Clinic |
ClinicalTrials.gov Identifier | NCT02086526 |
First Received | March 11, 2014 |
Last Updated | March 18, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | March 11, 2014 |
---|---|
Last Updated Date | March 18, 2014 |
Start Date | March 2014 |
Estimated Primary Completion Date | March 2016 |
Current Primary Outcome Measures | Change 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 Measures | Change 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 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 |
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 Type | Interventional |
Study Phase | Phase 1 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science |
Condition | Polycystic Ovary Syndrome |
Intervention | Drug: 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 Status | Recruiting |
---|---|
Estimated Enrollment | 150 |
Estimated Completion Date | March 2016 |
Estimated Primary Completion Date | March 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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02086526 |
---|---|
Other Study ID Numbers | 13-000692 |
Has Data Monitoring Committee | No |
Information Provided By | Mayo Clinic |
Study Sponsor | Mayo Clinic |
Collaborators | Not Provided |
Investigators | Principal Investigator: Alice Chang, MD Mayo Clinic |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
Mayo Clinic in Rochester | Rochester, Minnesota, United States, 55905 Contact: Tammi R Johnson | 507-255-6940 | johnson.tammi@mayo.eduPrincipal Investigator: Alice Y Chang, MD Recruiting |
---|