Obesity and Weight Loss on Reproductive Function

NCT00143078 | Terminated

• 1 other identifier: 19366
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Reproduction; Weight Loss; Reproductive System

Outcome Measures

Primary Outcomes (1)

• Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months

  12 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Tobacco Settlement Grant: collaborator

Study Sites (1)

The Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood \& urine

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Richard Legro, M.D.

  Penn State University/Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: June 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

US (1)