Oral Administration of DCI to Women With PCOS

Study Overview
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Brief Summary
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To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood, and, if so, if that change is accompanied by i) an increase in DCI-IPG release in blood (as determined by bioactivity) during an oral glucose challenge and ii) an increase in whole-body insulin sensitivity.

Detailed Description
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A total of 46 women will be studied. We will study 23 obese and 23 non-obese women. There will be no BMI restriction. Twenty-three women will be randomly assigned to receive DCI (experimental group) and 23 women to receive placebo (control group). The women will be studied during the equivalent of the follicular phase of the cycle, as documented by a serum progesterone concentration of 2 ng/ml. PCOS will be defined using criteria developed at the 1990 NICHD conference on PCOS3 - i.e., all women will have oligomenorrhea (eight or fewer menstrual periods annually) and hyperandrogenemia (elevated serum total or free testosterone concentration), and secondary causes of hyperandrogenism or ovulatory dysfunction will be excluded (see below: Entrance Criteria). All women will undergo a standard oral glucose tolerance test (OGTT) to screen for diabetes mellitus,16 but impaired glucose tolerance (IGT) will not be an exclusion criteria because of the high prevalence of IGT in this population.8,17-19 We intentionally will not screen the women for the presence of insulin resistance. Women with PCOS who have disorders associated with insulin resistance - such as hypertension21-23 or dyslipidemia21-23 - will not be excluded as long as they have been on a stable dose of medication for 6 months.

Official Title
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Determination if Oral DCI Administration to Women With PCOS Increases Total DCI Content in Urine and Blood...

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: DCI
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:- (1) Non-obese and obese women with PCOS between 18-40 years of age. (2) oligomenorrhea ( 8 menstrual periods annually), (3) biochemical hyperandrogenemia (elevated total or free testosterone), (4) normal thyroid function tests and serum prolactin, and (5) exclusion of 21 -hydroxylase deficiency by a fasting 17 -hydroxyprogesterone <200 ng/dl.41 (6) acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis). (7) Signed, witnessed informed consent. (8) 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, DepoProvera or Norplant.. (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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCI<br> | Drug: DCI<br>* D-chiro-inositol 1200mg twicely daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, twice daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood. |  | 43 days |