Clinical trial NCT00143078: Obesity and Weight Loss on Reproductive Function
Official title: The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: Obesity
Reproduction
Weight Loss
Reproductive System
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Tobacco Settlement Grant
First posted: 2005-09-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
measure: Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: The Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University/Milton S. Hershey Medical Center
name: Richard Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References: