Oral Administration of DCI to Women With PCOS
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.
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.
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.