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Insulin and Polycystic Ovary Syndrome

Primary Purpose

PCOS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diazoxide
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCOS subjects

Normal subjects

Arm Description

PCOS subjects given diazoxide

Normal subjects given diazoxide

Outcomes

Primary Outcome Measures

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
Level of Circulating D-chiro Inositol (DCI)
Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide

Secondary Outcome Measures

Full Information

First Posted
May 21, 2008
Last Updated
June 9, 2017
Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00683774
Brief Title
Insulin and Polycystic Ovary Syndrome
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCOS subjects
Arm Type
Experimental
Arm Description
PCOS subjects given diazoxide
Arm Title
Normal subjects
Arm Type
Active Comparator
Arm Description
Normal subjects given diazoxide
Intervention Type
Drug
Intervention Name(s)
diazoxide
Intervention Description
100mg orally three times per day for 10 days
Primary Outcome Measure Information:
Title
Renal Clearance of D-chiroinositol (DCI) at 12 Days
Description
Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay
Time Frame
12 days
Title
Level of Circulating D-chiro Inositol (DCI)
Description
Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide
Time Frame
12 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E. Nestler, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.vcu.edu/pcos
Description
Related Info

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Insulin and Polycystic Ovary Syndrome

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