Insulin and Polycystic Ovary Syndrome

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Sponsorii

Virginia Commonwealth University

Colaboratori

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

STUDIU CLINIC: NCT00683774

BioSeek: nct00683774

Cuvinte cheie

Abstract

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.

Datele

Ultima verificare:	05/31/2017
Primul depus:	05/20/2008
Inscriere estimată trimisă:	05/21/2008
Prima postare:	05/22/2008
Ultima actualizare trimisă:	06/08/2017
Ultima actualizare postată:	06/13/2017
Data primelor rezultate transmise:	05/29/2014
Data primelor rezultate QC trimise:	08/18/2014
Data primelor rezultate postate:	08/20/2014
Data actuală de începere a studiului:	10/31/2005
Data estimată de finalizare primară:	11/30/2008
Data estimată de finalizare a studiului:	11/30/2008

Stare sau boală

PCOS

Intervenție / tratament

Drug: diazoxide

Fază

Grupuri de brațe

Braţ	Intervenție / tratament
Experimental: PCOS subjects PCOS subjects given diazoxide
Active Comparator: Normal subjects Normal subjects given diazoxide

Criterii de eligibilitate

Vârste eligibile pentru studiu	18 Years La 18 Years
Sexe eligibile pentru studiu	Female
Acceptă voluntari sănătoși	da
Criterii	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.

Rezultat

Măsuri de rezultate primare

1. Renal Clearance of D-chiroinositol (DCI) at 12 Days [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) [12 days]

Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide

Insulin and Polycystic Ovary Syndrome

Cuvinte cheie

inozitol

obezitate

chiro inositol

d chiro inositol