Insulin and Polycystic Ovary Syndrome

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-12-31

Brief Summary

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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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Detailed Description

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Conditions

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PCOS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCOS subjects

PCOS subjects given diazoxide

Group Type EXPERIMENTAL

diazoxide

Intervention Type DRUG

100mg orally three times per day for 10 days

Normal subjects

Normal subjects given diazoxide

Group Type ACTIVE_COMPARATOR

diazoxide

Intervention Type DRUG

100mg orally three times per day for 10 days

Interventions

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diazoxide

100mg orally three times per day for 10 days

Intervention Type DRUG

Eligibility Criteria

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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