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

July 6, 2011
February 5, 2013
June 2011
January 2016   (final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01389778 on ClinicalTrials.gov Archive Site
  • Androgen Levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ovulatory Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Polycystic Ovary Syndrome Genetics and Treatment Response
Polycystic Ovary Syndrome Genetics and Treatment Response

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Metformin ER
    Metformin ER 1500 mg for 12 weeks
  • Drug: Metformin
Experimental: Metformin
Subjects treated with metformin.
Interventions:
  • Drug: Metformin ER
  • Drug: Metformin
Pau CT, Keefe C, Duran J, Welt CK. Metformin improves glucose effectiveness, not insulin sensitivity: predicting treatment response in women with polycystic ovary syndrome in an open-label, interventional study. J Clin Endocrinol Metab. 2014 May;99(5):1870-8. doi: 10.1210/jc.2013-4021. Epub 2014 Feb 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact: Corrine Welt, MD 617-726-8437 cwelt@partners.org
United States
 
NCT01389778
2010-P-002945
Yes
Corrine Welt, Massachusetts General Hospital
Massachusetts General Hospital
American Diabetes Association
Not Provided
Massachusetts General Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP