Reproductive Hormonal Alterations in Obesity

Completed · Not applicable

Conditions studied: Obesity

In brief

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 of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined. --Hypotheses: 1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

Key facts

Study ID

NCT01457703

Run by

University of Colorado, Denver

People needed

62

Starts

2010-06-01

Expected to finish

2013-07-01

Last updated by the study team

2017-01-12

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Translational Research Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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