Status:

COMPLETED

Insulin and Polycystic Ovary Syndrome

Lead Sponsor:

Virginia Commonwealth University

Collaborating Sponsors:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

PCOS

Eligibility:

FEMALE

18-40 years

Phase:

NA

Brief Summary

Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin st...

Eligibility Criteria

Inclusion

  • Obese women with PCOS and normal women aged 18-40,
  • PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia
  • Normal regular monthly periods, no clinical evidence of androgen excess,
  • All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements

Exclusion

  • DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.

Key Trial Info

Start Date :

November 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT00683774

Start Date

November 1 2005

End Date

December 1 2008

Last Update

June 14 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

General Clinical Research Center

Richmond, Virginia, United States, 23298

Insulin and Polycystic Ovary Syndrome | DecenTrialz