Polycystic Ovary Syndrome Genetics and Treatment Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01389778
First received: July 6, 2011
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age women. Women with PCOS have a high risk of prediabetes, type 2 diabetes and heart disease. The investigators have found a possible change in the DNA (genes of the body that encode all of our traits) that seems to be related to insulin resistance. In this study, the investigators will try to determine whether the change in the gene affects a woman's ability to respond to a common treatment for PCOS, metformin.

These studies will uncover the change in a gene that might be one of the causes of PCOS. Discovering this gene will help better understand the diabetes and insulin abnormalities that are common in PCOS and will help us to better diagnose and treat PCOS to prevent the diabetes in these women.


Condition Intervention
Polycystic Ovary Syndrome
Drug: Metformin ER
Drug: Metformin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Polycystic Ovary Syndrome Genetics and Treatment Response

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Androgen Levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ovulatory Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Subjects treated with metformin.
Drug: Metformin ER
Metformin ER 1500 mg for 12 weeks
Drug: Metformin

Detailed Description:

Polycystic ovary syndrome (PCOS), which affects 7-10% of reproductive aged women, has traditionally been classified as a reproductive and dermatologic syndrome because of its high rate of infertility and the cosmetic complications of hyperandrogenism. However, it has become increasingly clear that insulin resistance is important in the pathogenesis of the disorder.

There are a number of variants that have been determined to be associated with PCOS risk. The investigators will determine the effect of these variants on the phenotype and response to treatment in PCOS. Subjects with PCOS will undergo extensive phenotyping including adipose tissue biopsy, dual energy X-ray absorptiometry (DXA, bone density) scan to examine adipose stores, an intravenous glucose tolerance test to study insulin sensitivity and beta cell function, androgen stimulation and inflammatory markers. The phenotyping will be repeated after 3 months of treatment with metformin. The studies will determine whether the genotype at PCOS risk variants dictates phenotype and response to treatment with metformin. Discovering genes involved in the etiology of PCOS will help pull us out of the endless circle that has characterized our understanding of PCOS pathophysiology for many years. The proposal also has the potential to illuminate one etiology of insulin resistance, which is present even in lean women with PCOS, and the impaired glucose tolerance and diabetes found in over 40% of PCOS patients.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Polycystic ovary syndrome
  • No medications for 1 month
  • Good general health

Exclusion Criteria:

  • Smoker
  • Acute infection or chronic disease
  • Diabetes
  • Trying to get pregnant
  • Bleeding disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389778

Contacts
Contact: Corrine Welt, MD 617-726-8437 cwelt@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Corrine Welt, MD         
Sponsors and Collaborators
Massachusetts General Hospital
American Diabetes Association
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corrine Welt, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01389778     History of Changes
Other Study ID Numbers: 2010-P-002945
Study First Received: July 6, 2011
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014