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Insulin and Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT00683774
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : August 21, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
PCOS Drug: diazoxide Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Diazoxide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PCOS subjects
PCOS subjects given diazoxide
Drug: diazoxide
100mg orally three times per day for 10 days
Active Comparator: Normal subjects
Normal subjects given diazoxide
Drug: diazoxide
100mg orally three times per day for 10 days



Primary Outcome Measures :
  1. Renal Clearance of D-chiroinositol (DCI) at 12 Days [ Time Frame: 12 days ]
    Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay

  2. Level of Circulating D-chiro Inositol (DCI) [ Time Frame: 12 days ]
    Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683774


Locations
United States, Virginia
General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: John E. Nestler, MD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00683774     History of Changes
Other Study ID Numbers: VCU IRB 4479
2R01HD035629-09A2 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2008    Key Record Dates
Results First Posted: August 21, 2014
Last Update Posted: June 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Diazoxide
Antihypertensive Agents
Vasodilator Agents