Insulin and Polycystic Ovary Syndrome

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: PCOS

Treatments: Drug: diazoxide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00683774

2R01HD035629-09A2 (U.S. NIH Grant/Contract)

VCU IRB 4479

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups

PCOS subjects

Experimental group

Description:

PCOS subjects given diazoxide

Treatment:

Drug: diazoxide

Normal subjects

Active Comparator group

Description:

Normal subjects given diazoxide

Treatment:

Drug: diazoxide