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Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of DCI and Increases Circulating DCI in Obese Women With PCOS


N/A
18 Years
40 Years
Not Enrolling
Female
PCOS

Thank you

Trial Information

Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of DCI and Increases Circulating DCI in Obese Women With PCOS


Inclusion Criteria:



- 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 Criteria:

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement of insulin sensitivity by 1)decreasing the renal clearance of DCI and 2)increasing the circulating concentration of DCI

Outcome Time Frame:

12 days

Safety Issue:

No

Principal Investigator

John E. Nestler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Federal Government

Study ID:

VCU IRB 4479

NCT ID:

NCT00683774

Start Date:

November 2005

Completion Date:

December 2008

Related Keywords:

  • PCOS
  • Polycystic Ovary Syndrome

Name

Location
General Clinical Research Center Richmond, Virginia  23298