Clinical trial NCT03188640: Bariatric Surgery, Hormones, and Quality of Life
Official title: Health-related Quality of Life, Sexuality and Hormone Status After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hormone Disturbance
Quality of Life
Hyperandrogenism
Keywords: Bariatric surgery
Sex hormones
Women
Quality of life
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2017-06-15
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: With-in group comparison of pre- and postoperative data.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Premenpausal women
* BMI \>30
* Undergoing laparoscopic gastric bypass surgery

Exclusion Criteria:

* Smoking
* Liver disease
* Concomitant hormone treatment including all forms of hormone-based contraception

Primary outcomes:
measure: Sex-hormone levels
timeFrame: 1 year
measure: Female sexual function
timeFrame: 1 year
measure: Hormone-related quality of life
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between hormone levels and questionnaire results.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Sweden.
name: Mikael Wirén, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
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