Bariatric Surgery, Hormones, and Quality of Life (OBLIV)

Linköping University (LiU)

Status: Completed

Conditions: Hyperandrogenism; Quality of Life; Hormone Disturbance; Obesity

Treatments: Procedure: Laparoscopic gastric-bypass surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03188640

2012/392-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Surgery

Other group

Description:

Participants will be operated using laparoscopic gastric bypass surgery.

Treatment:

Procedure: Laparoscopic gastric-bypass surgery