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OpenTrials
Completed

NCT Number: NCT00683774

Insulin and Polycystic Ovary Syndrome

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.

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Key information

Conditions

PCOS

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Clinical Research Center

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diazoxide

Drug

100mg orally three times per day for 10 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 23, 2008
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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