Insulin and Polycystic Ovary Syndrome
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)
2 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
August 21, 2014
CompletedJune 14, 2017
June 1, 2017
3.1 years
May 21, 2008
May 30, 2014
June 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Level of Circulating D-chiro Inositol (DCI)
Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide
12 days
Study Arms (2)
PCOS subjects
EXPERIMENTALPCOS subjects given diazoxide
Normal subjects
ACTIVE COMPARATORNormal subjects given diazoxide
Interventions
Eligibility Criteria
You may qualify if:
- Obese women with PCOS and normal women aged 18-40,
- 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
You may not qualify if:
- DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Clinical Research Center
Richmond, Virginia, 23298, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Nestler
- Organization
- Virginia Commonwealth University
Study Officials
- PRINCIPAL INVESTIGATOR
John E. Nestler, MD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
November 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 14, 2017
Results First Posted
August 21, 2014
Record last verified: 2017-06