ObesityOBLIVNCT03188640
Bariatric Surgery, Hormones, and Quality of Life
A study testing Laparoscopic gastric-bypass surgery in people with Obesity and Hormone Disturbance, run by Linkoeping University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity, Hormone Disturbance, Quality of Life
- What is being tested?
- Laparoscopic gastric-bypass surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenpausal women
- BMI >30
- Undergoing laparoscopic gastric bypass surgery
Who cannot join
- Smoking
- Liver disease
- Concomitant hormone treatment including all forms of hormone-based contraception
About this study
Official title: Health-related Quality of Life, Sexuality and Hormone Status After Bariatric Surgery
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.
Read the 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.
- Conditions
- Obesity, Hormone Disturbance, Quality of Life, Hyperandrogenism
- Being tested
- Laparoscopic gastric-bypass surgery
- Keywords
- Bariatric surgery, Sex hormones, Women, Quality of life
- Medical subject headings
- Obesity, Endocrine System Diseases, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic gastric-bypass surgeryProcedure or surgery
Female participants with BMI >30, between age 18-50, will be operated with laparoscopic gastric bypass surgery by an experienced gastric bypass surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Participants will be operated using laparoscopic gastric bypass surgery. Receives: Procedure: Laparoscopic gastric-bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
Correlation between hormone levels and questionnaire results.
Analysis of possible correlations between the change in hormone levels and survey scores 1-year postoperatively.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Mar 2014
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- With-in group comparison of pre- and postoperative data.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rebecca Paul, Linkoeping University
- Investigators
- Mikael Wirén, M.D., PhD., Principal investigator, Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188640
- Sponsor's protocol ID
- 2012/392-31
- Acronym
- OBLIV
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-indentified individual participant data can be made available for primary and secondary outcomes, upon request, after study completion and manuscript publication.
Publications
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.
PubMed 23303913Tchernof 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.
PubMed 11246820Kolotkin 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.
PubMed 16648619Sarwer 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.
PubMed 22293982Esposito 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.
PubMed 17287832Gosman 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.
PubMed 19815190Malik 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.
PubMed 22532886Bond 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.
PubMed 20678969Botwood 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.
PubMed 7626505Sarwer 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.
PubMed 24190440
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life, Sexuality and Hormone Status After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03188640
- Acronym / sponsor ID
- OBLIV / 2012/392-31
- Conditions
- Obesity, Hormone Disturbance, Quality of Life, Hyperandrogenism
- Keywords
- Bariatric surgery, Sex hormones, Women, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- With-in group comparison of pre- and postoperative data.
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: Laparoscopic gastric-bypass surgeryParticipants will be operated using laparoscopic gastric bypass surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenpausal women
- BMI >30
- Undergoing laparoscopic gastric bypass surgery
Key exclusion criteria (3 listed)
- Smoking
- Liver disease
- Concomitant hormone treatment including all forms of hormone-based contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic gastric-bypass surgeryFemale participants with BMI >30, between age 18-50, will be operated with laparoscopic gastric bypass surgery by an experienced gastric bypass surgeon. | Procedure or surgery | Surgery |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Correlation between hormone levels and questionnaire results.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 23303913Tchernof A, Despres JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011.
- Background: PubMed 11246820Tchernof 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.
- Background: PubMed 16648619Kolotkin 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.
- Background: PubMed 22293982Sarwer 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.
- Background: PubMed 17287832Esposito 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.
- Background: PubMed 19815190Gosman 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.
- Background: PubMed 22532886Malik 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.
- Background: PubMed 20678969Bond 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.
- Background: PubMed 7626505Botwood 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.
- Background: PubMed 24190440Sarwer 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.
- Individual participant dataSharing planned: No. De-indentified individual participant data can be made available for primary and secondary outcomes, upon request, after study completion and manuscript publication.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Wirén, M.D., PhD. principal investigator
Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Sweden.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic gastric-bypass surgery in people with Obesity and Hormone Disturbance, run by Linkoeping University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sex-hormone levels (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188640, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.