Determination if Indirectly Reducing Circulating Insulin by Improving Insulin Sensitivity With Pioglitazone, Decreases Renal Clearance of DCI, Increases the Circulating Concentration of DCI, and Enhances Insulin-stimulated Release of the DCI-IPG Mediator in Obese Women With PCOS
18 Years
40 Years
Female
Polycystic Ovary Syndrome
Trial Information
Determination if Indirectly Reducing Circulating Insulin by Improving Insulin Sensitivity With Pioglitazone, Decreases Renal Clearance of DCI, Increases the Circulating Concentration of DCI, and Enhances Insulin-stimulated Release of the DCI-IPG Mediator in Obese Women With PCOS
This protocol focuses on the hypothesis that a deficiency in a putative
inositolphosphoglycan (IPG) mediator of insulin action, namely a D-chiro-inositol-containing
IPG (DCI-IPG), contributes to the insulin resistance of some women with PCOS. Our interest
in this area stems directly from our previous studies, which demonstrated that
administration of the precursor, D-chiro-inositol (DCI), to both obese23 and lean24 women
with PCOS improved glucose intolerance while reducing circulating insulin, and
simultaneously improved ovulatory function and decreased serum androgens. These findings
were recently confirmed in a large-scale study by an independent group.25 The findings of
these three studies suggested that administration of DCI improved insulin sensitivity in
PCOS, which then resulted in an improved hormonal and metabolic milieu.
Inclusion Criteria:
1. Obese (BMI greater than or equal to 30 kg/m2) women with PCOS between 18-40 years of
age:
- oligomenorrhea (less than 8 menstrual periods annually)
- biochemical hyperandrogenemia (elevated total or free testosterone)
- normal thyroid function tests and serum prolactin; AND
- exclusion of 21a-hydroxylase deficiency by a fasting 17a-hydroxyprogesterone
less than 200 ng/dl.51,
2. acceptable health on the basis of interview, medical history, physical examination,
and laboratory tests (CBC, SMA20, urinalysis, negative pregnancy test).
3. Signed, witnessed informed consent.
4. Ability to comply with study requirements.
Exclusion Criteria:
1. Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary,
cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and
malignant disease (other than non-melanoma skin cancer).
2. Current use of oral contraceptives.
3. Documented or suspected recent (within one year) history of drug abuse or alcoholism.
4. Ingestion of any investigational drug within two months prior to study onset.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
Outcome Measure:
DCI-IPG and DCI measurements in blood and urine
Outcome Time Frame:
2 years
Safety Issue:
No
Authority:
United States: Federal Government
Study ID:
VCUIRB4480
NCT ID:
NCT00868140
Start Date:
February 2009
Completion Date:
August 2012
Related Keywords:
- Polycystic Ovary Syndrome
- Polycystic Ovary Syndrome
Name | Location |
|---|---|
| Virginia Commonwealth University General Clinical Research Center | Richmond, Virginia 23298 |
