Oral Administration of DCI to Women With PCOS
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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...|
- To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood. [ Time Frame: 43 days ] [ Designated as safety issue: No ]
|Study Start Date:||February 2001|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
D-chiro-inositol 1200mg twicely daily for 6 weeks
|Placebo Comparator: Placebo||
Placebo, twice daily for 6 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497653
|United States, Virginia|
|General Clinical Research Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||John E. Nestler, MD||Virginia Commonwealth University|