Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
Ключови думи
Резюме
Описание
- Design: paired assessments Pre and Post estrogen administration in obese and normal weight women
- AIM 1: To test the pituitary and hypothalamic responsiveness in obesity, we will examine the luteinizing hormone (LH) and follicle-stimulating hormone (FSH) pulsatility during frequent blood sampling.
- AIM 2: To test the ovarian responsiveness in obesity, we will examine urinary reproductive hormones (E1c, estrone conjugates, and Pdg, pregnanediol glucuronide) over an entire menstrual cycle.
- AIM 3: To test the hypothesis that central adiposity is associated with reproductive hormone alterations in obesity, we will quantitatively assess body composition by dual energy x-ray absorptiometry (DXA).
Дати
| Последна проверка: | 03/31/2015 |
| Първо изпратено: | 06/21/2011 |
| Очаквано записване подадено: | 06/21/2011 |
| Първо публикувано: | 06/26/2011 |
| Изпратена последна актуализация: | 04/01/2015 |
| Последна актуализация публикувана: | 04/19/2015 |
| Дата на първите подадени резултати: | 02/01/2015 |
| Дата на първите подадени резултати от QC: | 02/01/2015 |
| Дата на първите публикувани резултати: | 02/17/2015 |
| Действителна начална дата на проучването: | 05/31/2011 |
| Приблизителна дата на първично завършване: | 12/31/2012 |
| Очаквана дата на завършване на проучването: | 12/31/2012 |
Състояние или заболяване
Интервенция / лечение
Drug: Estradiol
Drug: Gonadotropin-releasing hormone (GnRH)
Drug: Progesterone
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Other: Group 1 - Normal Weight Group 1: Normal weight (BMI 18-25 kg/m2)
Subjects were instructed to apply 0.1 mg/d transdermal estrogen (Estradiol) for one month. Pituitary response was assessed to determine how estradiol administration altered pituitary sensitivity to Gonadotropin-releasing hormone - GnRH. Subjects who failed to initiate a menstrual period following 40 days on the patch were instructed to take 200 mg daily of progesterone for 10 days or as long as deemed necessary. | |
| Experimental: Group 2 - Obese Group 2: Obese (BMI >30 kg/m2)
Subjects were instructed to apply 0.1 mg/d transdermal estrogen (Estradiol) for one month. Pituitary response was assessed to determine how estradiol administration altered pituitary sensitivity to Gonadotropin-releasing hormone - GnRH. Subjects who failed to initiate a menstrual period following 40 days on the patch were instructed to take 200 mg daily of progesterone for 10 days or as long as deemed necessary. |
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: - Age 18-42 at study entry - Regular menstrual cycles every 25-40 days - BMI 18- 25 kg/m2 or ≥30kg/m2 - Good general health - Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening - Baseline hemoglobin >11 gm/dl. Exclusion Criteria: - Positive screen for Activated Protein C resistance - Any contraindications to exogenous estrogen, including previous thromboembolic events or stroke, history of an estrogen-dependent tumor, active liver disease, undiagnosed abnormal uterine bleeding, hypertriglyceridemia, smoking, hypertension - History of chronic disease affecting hormone production, metabolism or clearance (including diabetes mellitus) or abnormal renal or liver function at screening, such as elevated aspartate or alanine aminotransferases or elevated blood urea nitrogen (BUN) or creatinine - Current use of thiazolidinediones or metformin (known to interact with reproductive hormones) - Use of hormones affecting hypothalamic-pituitary ovarian axis within three months of enrollment - Strenuous exercise (>4 hours per week) - Pregnancy, breast-feeding or current active attempts to conceive |
Резултат
Първични изходни мерки
1. Luteinizing Hormone Pulse Amplitude [Baseline]
2. Luteinizing Hormone Pulse Amplitude [Post estradiol at one month]
