Bariatric Surgery, Hormones, and Quality of Life

NCT03188640 | Completed

• 1 other identifier: 2012/392-31
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Hormone Disturbance; Quality of Life; Hyperandrogenism

Keywords

Bariatric surgery; Sex hormones; Women; Quality of life

Outcome Measures

Primary Outcomes (4)

• Sex-hormone levels

  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.

  1 year

• Female sexual function

  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.

  1 year

• Hormone-related quality of life

  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.

  1 year

• Health-related quality of life

  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.

  1 year

Secondary Outcomes (1)

• Correlation between hormone levels and questionnaire results.

  1 year

Study Arms (1)

Surgery

OTHER

Participants will be operated using laparoscopic gastric bypass surgery.

Procedure: Laparoscopic gastric-bypass surgery

Interventions

Laparoscopic gastric-bypass surgery PROCEDURE

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

Surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Biological female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Related Publications (10)

• Tchernof A, Despres JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011.

  PMID: 23303913 BACKGROUND

• Tchernof A, Despres JP. Sex steroid hormones, sex hormone-binding globulin, and obesity in men and women. Horm Metab Res. 2000 Nov-Dec;32(11-12):526-36. doi: 10.1055/s-2007-978681.

  PMID: 11246820 BACKGROUND

• Kolotkin RL, Binks M, Crosby RD, Ostbye T, Gress RE, Adams TD. Obesity and sexual quality of life. Obesity (Silver Spring). 2006 Mar;14(3):472-9. doi: 10.1038/oby.2006.62.

  PMID: 16648619 BACKGROUND

• Sarwer DB, Lavery M, Spitzer JC. A review of the relationships between extreme obesity, quality of life, and sexual function. Obes Surg. 2012 Apr;22(4):668-76. doi: 10.1007/s11695-012-0588-1.

  PMID: 22293982 BACKGROUND

• Esposito K, Ciotola M, Giugliano F, Bisogni C, Schisano B, Autorino R, Cobellis L, De Sio M, Colacurci N, Giugliano D. Association of body weight with sexual function in women. Int J Impot Res. 2007 Jul-Aug;19(4):353-7. doi: 10.1038/sj.ijir.3901548. Epub 2007 Feb 8.

  PMID: 17287832 BACKGROUND

• Gosman GG, King WC, Schrope B, Steffen KJ, Strain GW, Courcoulas AP, Flum DR, Pender JR, Simhan HN. Reproductive health of women electing bariatric surgery. Fertil Steril. 2010 Sep;94(4):1426-1431. doi: 10.1016/j.fertnstert.2009.08.028. Epub 2009 Oct 7.

  PMID: 19815190 BACKGROUND

• Malik SM, Traub ML. Defining the role of bariatric surgery in polycystic ovarian syndrome patients. World J Diabetes. 2012 Apr 15;3(4):71-9. doi: 10.4239/wjd.v3.i4.71.

  PMID: 22532886 BACKGROUND

• Bond DS, Wing RR, Vithiananthan S, Sax HC, Roye GD, Ryder BA, Pohl D, Giovanni J. Significant resolution of female sexual dysfunction after bariatric surgery. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):1-7. doi: 10.1016/j.soard.2010.05.015. Epub 2010 Jun 4.

  PMID: 20678969 BACKGROUND

• Botwood N, Hamilton-Fairley D, Kiddy D, Robinson S, Franks S. Sex hormone-binding globulin and female reproductive function. J Steroid Biochem Mol Biol. 1995 Jun;53(1-6):529-31. doi: 10.1016/0960-0760(95)00108-c.

  PMID: 7626505 BACKGROUND

• Sarwer DB, Spitzer JC, Wadden TA, Mitchell JE, Lancaster K, Courcoulas A, Gourash W, Rosen RC, Christian NJ. Changes in sexual functioning and sex hormone levels in women following bariatric surgery. JAMA Surg. 2014 Jan;149(1):26-33. doi: 10.1001/jamasurg.2013.5022.

  PMID: 24190440 BACKGROUND

MeSH Terms

Conditions

Obesity; Endocrine System Diseases; Hyperandrogenism

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders

Study Officials

• Mikael Wirén, M.D., PhD.

  Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Sweden.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: With-in group comparison of pre- and postoperative data.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: March 1, 2014
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share