Oral Administration of DCI to Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00497653
• Other study ID #: 2R01HD35629 P2
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 5, 2007
• Last updated: November 15, 2011
• Start date: February 2001
• Est. completion date: July 2009

Study information

• Verified date: November 2011
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• DCI
D-chiro-inositol 1200mg twicely daily for 6 weeks
• Placebo
Placebo, twice daily for 6 weeks

Locations

Country	Name	City	State
United States	General Clinical Research Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood.		43 days	No