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Insulin and Polycystic Ovary Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00683774
First received: May 21, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention
PCOS
Drug: diazoxide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Renal Clearance of D-chiroinositol (DCI) at 12 Days [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide


Enrollment: 21
Study Start Date: November 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683774

Locations
United States, Virginia
General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: John E. Nestler, MD Virginia Commonwealth University
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00683774     History of Changes
Other Study ID Numbers: VCU IRB 4479, 2R01HD035629-09A2
Study First Received: May 21, 2008
Results First Received: May 30, 2014
Last Updated: August 19, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 27, 2014