Obesity Clinical Trial
Official title:
Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
The sole purpose of this study is to evaluate pathophysiology of disease. The disease state
that is being evaluated is the obesity-related alterations in reproductive hormones
- The obesity epidemic in the United States is advancing at an accelerated pace. It is
estimated that by 2015, 41% of U.S. adults will be obese as defined by a body mass
index (BMI) of greater than 30 kg/m2. The U.S. government's 2010 Dietary Guidelines
regard obesity as the single greatest health hazard in this century. Female adult
obesity is associated with menstrual cycle irregularities, ovulatory dysfunction and a
higher risk of obstetrical complications. This reproductive phenotype of obesity is
worsened by further increases in BMI and is not solely due to anovulatory infertility.
While the association of adiposity with subfertility is well documented in population
studies, the underlying mechanisms remain poorly understood. The main objective of this
proposal is to clarify the nature of the obesity-related reproductive endocrine
abnormalities and identify potential etiologies amenable to therapy.
- Hypothesis: The hypothalamic-pituitary axis is abnormally sensitive to estradiol
negative feedback in obesity.
- 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).
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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