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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Targeting Pathophysiologic Pathways in Polycystic Ovary Syndrome Using a Response to Metformin Phenotype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086526
• Other study ID #: 13-000692
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2014
• Last updated: March 15, 2018
• Start date: March 2014
• Est. completion date: November 20, 2016

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 20, 2016
• Est. primary completion date: November 20, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Weight		baseline, 3 months
Other	Change in Testosterone		baseline, 3 months
Primary	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	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).	baseline, 3 months