Obesity and Weight Loss on Reproductive Function - Full Text View

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.

Condition	Phase
Obesity	Phase II

MedlinePlus related topics:

Obesity Weight Control Weight Loss Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model

Further study details as provided by Penn State University:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood & urine

Estimated Enrollment:	40
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2010

Detailed Description:

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

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143078

Contacts


Contact: Sandra S Eyer	717-531-1540	seyer@psu.edu

Locations


United States, Pennsylvania
	The Penn State Hershey Medical Center	Recruiting
	Hershey, Pennsylvania, United States, 17033
	Principal Investigator: Richard S Legro, MD

Sponsors and Collaborators

Penn State University

Tobacco Settlement Grant

Investigators


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
First Received:	September 1, 2005
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00143078
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Obesity

Reproduction

Weight Loss

Reproductive System

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Weight Loss

Body Weight Changes

Nutrition Disorders

Overweight

Overnutrition

Obesity, Morbid

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	Penn State University Tobacco Settlement Grant
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00143078