Obesity and Weight Loss on Reproductive Function

November 13, 2015 updated by: Richard S. Legro, M.D., Milton S. Hershey Medical Center

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • The Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Tobacco Settlement Grant

Investigators

  • Principal Investigator: Richard Legro, M.D., Penn State University/Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19366

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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