Oral Administration of DCI to Women With PCOS (PCOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497653
Recruitment Status : Terminated
First Posted : July 9, 2007
Last Update Posted : November 16, 2011
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: DCI Drug: Placebo Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Determination if Oral DCI Administration to Women With PCOS Increases Total DCI Content in Urine and Blood...
Study Start Date : February 2001
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DCI Drug: DCI
D-chiro-inositol 1200mg twicely daily for 6 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo, twice daily for 6 weeks

Primary Outcome Measures :
  1. To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood. [ Time Frame: 43 days ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497653

United States, Virginia
General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institutes of Health (NIH)
Principal Investigator: John E. Nestler, MD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University Identifier: NCT00497653     History of Changes
Other Study ID Numbers: 2R01HD35629 P2
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases