Insulin and Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: PCOS
• Interventions: Drug: diazoxide

• Registration Number: NCT00683774
• Lead Sponsor: Virginia Commonwealth University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2014-05-30
• Results First Submitted QC: 2014-08-19
• Results First Posted: 2014-08-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCOS subjects	diazoxide	PCOS subjects given diazoxide
Normal subjects	diazoxide	Normal subjects given diazoxide

Primary Outcome Measures

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

Trial Locations

Locations (1)

General Clinical Research Center; 🇺🇸 Richmond, Virginia, United States