Estrogen Sensitivity and Ovulatory Dysfunction in Obesity
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | June 2011 |
| End Date: | October 2012 |
| Contact: | Jennifer Lesh, BA |
| Email: | jennifer.lesh@ucdenver.edu |
| Phone: | 303-724-2046 |
- 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
- AIM1: 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.
- AIM2: 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.
- AIM3: 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).
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 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 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
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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