Bariatric Surgery, Hormones, and Quality of Life (OBLIV)
Primary Purpose
Obesity, Hormone Disturbance, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic gastric-bypass surgery
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Bariatric surgery, Sex hormones, Women, Quality of life
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Surgery
Arm Description
Participants will be operated using laparoscopic gastric bypass surgery.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Correlation between hormone levels and questionnaire results.
Analysis of possible correlations between the change in hormone levels and survey scores 1-year postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03188640
Brief Title
Bariatric Surgery, Hormones, and Quality of Life
Acronym
OBLIV
Official Title
Health-related Quality of Life, Sexuality and Hormone Status After Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hormone Disturbance, Quality of Life, Hyperandrogenism
Keywords
Bariatric surgery, Sex hormones, Women, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
With-in group comparison of pre- and postoperative data.
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Other
Arm Description
Participants will be operated using laparoscopic gastric bypass surgery.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastric-bypass surgery
Intervention Description
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 Measure Information:
Title
Sex-hormone levels
Description
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.
Time Frame
1 year
Title
Female sexual function
Description
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.
Time Frame
1 year
Title
Hormone-related quality of life
Description
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.
Time Frame
1 year
Title
Health-related quality of life
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation between hormone levels and questionnaire results.
Description
Analysis of possible correlations between the change in hormone levels and survey scores 1-year postoperatively.
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Biological female.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Wirén, M.D., PhD.
Organizational Affiliation
Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Sweden.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-indentified individual participant data can be made available for primary and secondary outcomes, upon request, after study completion and manuscript publication.
Citations:
PubMed Identifier
23303913
Citation
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.
Results Reference
background
PubMed Identifier
11246820
Citation
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.
Results Reference
background
PubMed Identifier
16648619
Citation
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.
Results Reference
background
PubMed Identifier
22293982
Citation
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.
Results Reference
background
PubMed Identifier
17287832
Citation
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.
Results Reference
background
PubMed Identifier
19815190
Citation
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.
Results Reference
background
PubMed Identifier
22532886
Citation
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.
Results Reference
background
PubMed Identifier
20678969
Citation
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.
Results Reference
background
PubMed Identifier
7626505
Citation
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.
Results Reference
background
PubMed Identifier
24190440
Citation
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.
Results Reference
background
Learn more about this trial
Bariatric Surgery, Hormones, and Quality of Life
We'll reach out to this number within 24 hrs