Insulin and Polycystic Ovary Syndrome

PCOS Clinical Trial

Official title:

Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of D-Chiroinositol (DCI) and Increases Circulating DCI in Obese Women With Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683774
• Other study ID #: VCU IRB 4479
• Secondary ID: 2R01HD035629-09A
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: June 9, 2017
• Start date: November 2005
• Est. completion date: December 2008

Study information

• Verified date: June 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• PCOS
• Polycystic Ovary Syndrome

Intervention

Drug:
• diazoxide
100mg orally three times per day for 10 days

Locations

Country	Name	City	State
United States	General Clinical Research Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Clearance of D-chiroinositol (DCI) at 12 Days	Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay	12 days
Primary	Level of Circulating D-chiro Inositol (DCI)	Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide	12 days