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Trial record 57 of 107 for:    "21-hydroxylase deficiency"

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

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ClinicalTrials.gov Identifier: NCT03188640
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Rebecca Paul, 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.

Condition or disease Intervention/treatment Phase
Obesity Hormone Disturbance Quality of Life Hyperandrogenism Procedure: Laparoscopic gastric-bypass surgery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Intervention Model Description: With-in group comparison of pre- and postoperative data.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health-related Quality of Life, Sexuality and Hormone Status After Bariatric Surgery
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016


Arm Intervention/treatment
Surgery
Participants will be operated using laparoscopic gastric bypass surgery.
Procedure: Laparoscopic gastric-bypass surgery
Female participants with BMI >30, between age 18-50, will be operated with laparoscopic gastric bypass surgery by an experienced gastric bypass surgeon.




Primary Outcome Measures :
  1. Sex-hormone levels [ Time Frame: 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.

  2. Female sexual function [ Time Frame: 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.

  3. Hormone-related quality of life [ Time Frame: 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.

  4. Health-related quality of life [ Time Frame: 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 :
  1. Correlation between hormone levels and questionnaire results. [ Time Frame: 1 year ]
    Analysis of possible correlations between the change in hormone levels and survey scores 1-year postoperatively.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological female.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188640


Sponsors and Collaborators
Linkoeping University
Investigators
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Principal Investigator: Mikael Wirén, M.D., PhD. Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Sweden.

Publications:

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Responsible Party: Rebecca Paul, Dr., Linkoeping University
ClinicalTrials.gov Identifier: NCT03188640     History of Changes
Other Study ID Numbers: 2012/392-31
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-indentified individual participant data can be made available for primary and secondary outcomes, upon request, after study completion and manuscript publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Paul, Linkoeping University:
Bariatric surgery
Sex hormones
Women
Quality of life
Additional relevant MeSH terms:
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Adrenogenital Syndrome
Hyperandrogenism
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs