Clinical Trials Directory

Trials / Completed

CompletedNCT03188640

Bariatric Surgery, Hormones, and Quality of Life

Health-related Quality of Life, Sexuality and Hormone Status After Bariatric Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
68 (actual)
Sponsor
Linkoeping University · Other Government
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to characterize the hormonal status in fertile women undergoing laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation between health-related quality of life and proposed hormone changes post-operatively.

Detailed description

Sex hormone levels in women with obesity are altered in comparison to normal weight subjects. Most previous studies have focused on questionnaire surveys, and on the emotional/psychological aspect of health-related quality of life (HRQoL). It has been shown that bariatric surgery can affect reproductive ability, but the relationship between hormonal changes and HRQoL has been sparsely studied. Hormone balance is affected by fat allocation, insulin levels and liver function, and these factors are all influenced postoperatively. Also body image and altered body mass composition can influence sexuality in diverse ways. This leads us to theorize that liver production of SHBG will change after surgery and impact serum concentrations of sex hormones. Normalized levels of testosterone and estrogen may lead to reduced symptoms of hyperandrogenism, restitution of normal menstrual cycles and changes in sexual functioning. The focus of this study is to analyze sexual and health-related quality of life through questionnaire analyses, and to investigate levels of sex hormones pre- and postoperatively in women undergoing bariatric surgery. Results from questionnaire analyses and hormone data will be tested for possible correlations.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic gastric-bypass surgeryFemale participants with BMI \>30, between age 18-50, will be operated with laparoscopic gastric bypass surgery by an experienced gastric bypass surgeon.

Timeline

Start date
2014-03-01
Primary completion
2016-10-31
Completion
2016-10-31
First posted
2017-06-15
Last updated
2017-06-16

Source: ClinicalTrials.gov record NCT03188640. Inclusion in this directory is not an endorsement.