Bariatric Surgery, Hormones, and Quality of Life

Not Applicable

Completed

• Conditions: Obesity; Hormone Disturbance; Quality of Life; Hyperandrogenism
• Interventions: Procedure: Laparoscopic gastric-bypass surgery

• Registration Number: NCT03188640
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2017-06
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-15
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Laparoscopic gastric-bypass surgery	Participants will be operated using laparoscopic gastric bypass surgery.

Primary Outcome Measures

Name	Time	Method
Sex-hormone levels	1 year	Albumin, luteinizing hormone (LH), follicle stimulating hormone (FSH), sexual hormone binding globulin (SHBG), estradiol (E2), testosterone and progesterone were analyzed preoperatively, and one-year postoperatively.
Female sexual function	1 year	A survey of sexual function, the Female Sexual Function Index (FSFI), measures five separate domains of female sexual function: desire/arousal, lubrication, orgasm, satisfaction, and pain. These are assessed as desire (range 1.2-6); arousal (range 0-6); lubrication (range 0-6); orgasm (range 0-6); satisfaction (range 0.8-6) and pain (range 0.6-6). The separate domain scores are summed to create a total score with range 2-36, where totals less than 26 indicate female sexual dysfunction.
Hormone-related quality of life	1 year	The Women's Health Questionnaire (WHQ) was developed to assess hormonally-mediated changes that can occur during menopause, but also in other diseases that cause hormonal fluctuation. The following domains are covered by the questionnaire: depressed mood (6 items), somatic symptoms (7 items), anxiety/fears (4 items), vasomotor symptoms (2 items), sleep problems (3 items), sexual behavior (3 items), menstrual symptoms (4 items), memory/concentration (3 items) and attractiveness (3 items). The WHQ is scored by reducing the four point scales (yes definitely, yes sometimes, no not much, no not at all) to binary options (0/1) and the subscale items are summated and divided by the number of items in each subscale. The WHQ questionnaire scores range between zero and one. Zero reflects good health, and one, at the other end of the scale, shows negative health.
Health-related quality of life	1 year	The Psychological General Well-Being Survey (PGWB) was developed for the evaluation of perceived well-being and distress and is a 22 item instrument with six domains. Anxiety (range 0-25); Depressed Mood (range 0-15); Positive Well-Being (range 0-20); Self Control (range 0-15); General Health (range 0-15) and Vitality (range 0-20). Scores are summed giving a score range of 22-132, with lower scores indicating poorly perceived well-being.

Secondary Outcome Measures

Name	Time	Method
Correlation between hormone levels and questionnaire results.	1 year	Analysis of possible correlations between the change in hormone levels and survey scores 1-year postoperatively.