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| Sponsor: | Penn State University |
|---|---|
| Collaborator: |
Tobacco Settlement Grant |
| Information provided by: | Penn State University |
| ClinicalTrials.gov Identifier: | NCT00143078 |
Purpose
The purpose of this study is to examine how obesity and weight loss following bariatric surgery affect reproductive function. The study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. Specifically, we, the researchers at Penn State University, propose to characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the short-term effects of alteration in GI hormones after bariatric surgery on reproductive function. We hypothesize that bariatric surgery radically alters GI hormone expression, resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women. Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes in adipokines on reproductive function. We hypothesize that the changes in adipokine levels resulting from fat mass reduction lead to substantial long-term improvements in reproductive function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine levels following weight loss, with women experiencing larger changes than men.
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model |
whole blood & urine
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2010 |
Obesity may influence female reproduction through a variety of mechanisms including: suppressing ovulation; inhibiting ovarian follicular development; and altering endometrial development and implantation. In males, obesity may impair reproductive function by several mechanisms including: decreasing libido, causing erectile dysfunction, influencing semen composition, or sperm function. Therefore the long term goal of the current project is to understand the impact of severe obesity on reproductive function and how this is influenced by dramatic weight loss.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Participants eligible for bariatric surgery; BMI >40 or between 35 and 39.9 with a weight related health problem; Failed medical weight loss; Ages 18-40; Not using hormonal contraceptives; Females have not undergone and bilateral oophrectomy or hysterectomy; Males have not had a vasectomy
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| The Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: | Richard Legro, M.D. | Penn State University/Milton S. Hershey Medical Center |
More Information
| Responsible Party: | The Penn State University ( Richard S. Legro, M.D. ) |
| Study ID Numbers: | 19366 |
| Study First Received: | September 1, 2005 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00143078 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Reproduction Weight Loss Reproductive System |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |