Oral Administration of DCI to Women With PCOS
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 10/31/2011 |
| Първо изпратено: | 07/04/2007 |
| Очаквано записване подадено: | 07/04/2007 |
| Първо публикувано: | 07/08/2007 |
| Изпратена последна актуализация: | 11/14/2011 |
| Последна актуализация публикувана: | 11/15/2011 |
| Действителна начална дата на проучването: | 01/31/2001 |
| Приблизителна дата на първично завършване: | 06/30/2007 |
| Очаквана дата на завършване на проучването: | 06/30/2009 |
Състояние или заболяване
Интервенция / лечение
Drug: DCI
Drug: Placebo
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: DCI | Drug: DCI D-chiro-inositol 1200mg twicely daily for 6 weeks |
| Placebo Comparator: Placebo | Drug: Placebo Placebo, twice daily for 6 weeks |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | 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. |
Резултат
Първични изходни мерки
1. To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood. [43 days]
