N/A
N=21
Insulin and Polycystic Ovary Syndrome
PCOS
Bottom Line
View on ClinicalTrials.gov: NCT00683774 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Renal Clearance of D-chiroinositol (DCI) at 12 Days — 4.75; 5.16 ml/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- diazoxide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Clearance of D-chiroinositol (DCI) at 12 Days |
4.75; 5.16 | — |
| PRIMARY Level of Circulating D-chiro Inositol (DCI) |
0.27; 0.27 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00683774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.