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Completed

NCT Number: NCT02086526

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Primary outcomes

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

    Time frame: Baseline, 3 months

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

Secondary outcomes

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

    Time frame: baseline, 3 months

    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).

Other outcomes

  1. Change in Weight

    Time frame: baseline, 3 months

  2. Change in Testosterone

    Time frame: baseline, 3 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2014
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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