Status:
COMPLETED
Reproductive Hormonal Alterations in Obesity
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level ...
Detailed Description
AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the hypothesis that the hypo...
Eligibility Criteria
Inclusion
- Aged 18-40 at study entry
- BMI either 18-25 kg/m2 or ≥30 kg/m2
- prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
- Baseline hemoglobin \>11 gm/dl
- History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2
- History of regular menstrual cycles every 25-40 days if BMI ≥30 kg/m2
Exclusion
- History of chronic disease affecting hormone production, metabolism or clearance
- Use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin)
- Use of hormones within three months of enrollment
- Excessive exercise (\>4 hours per week)
- Pregnancy, breast-feeding or current active attempts to conceive
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01457703
Start Date
June 1 2010
End Date
July 1 2013
Last Update
January 12 2017
Active Locations (1)
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1
Clinical Translational Research Center
Aurora, Colorado, United States, 80045