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Obesity and Weight Loss on Reproductive Function
This study is ongoing, but not recruiting participants.
Study NCT00143078   Information provided by Penn State University
First Received: September 1, 2005   Last Updated: February 3, 2009   History of Changes

September 1, 2005
February 3, 2009
June 2005
 
 
 
Complete list of historical versions of study NCT00143078 on ClinicalTrials.gov Archive Site
 
 
 
Obesity and Weight Loss on Reproductive Function
The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model

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.

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.

Phase II
Observational
Cohort, Prospective
Obesity
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
December 2010
 

Inclusion Criteria:

  • Body mass index (BMI) of greater than 40 or a BMI between 35.5-39.9 and has a weight related health problem, such as diabetes or high blood pressure.
  • Failed medical weight loss
  • Ages of 18-40
  • Not using hormonal contraception or sex steroids
  • Subject is premenopausal and has not undergone a bilateral oophorectomy or hysterectomy
  • Subject's obesity has no medical explanation (hypothyroidism, Cushing's Syndrome, genetic)

Exclusion Criteria:

  • Not willing to make a lifelong commitment to the diet and exercise guidelines following bariatric surgery
  • Subject is pregnant or lactating
  • Not willing to use barrier contraceptives or intrauterine device (IUD) to prevent pregnancy for one year following bariatric surgery
  • Post-menopausal, either surgical or natural
  • Subject has had a vasectomy
  • Subject is a smoker
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00143078
Richard S. Legro, M.D., The Penn State University
19366
Penn State University
Tobacco Settlement Grant
Principal Investigator: Richard Legro, M.D. Penn State University/Milton S. Hershey Medical Center
Penn State University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP