ObesityNCT00670098
Changes in Sexual Function Following Bariatric Surgery
A study testing Bariatric surgery and lifestyle intervention (behavioral weight loss) in people with Obesity, run by University of Pennsylvania.
Trial summary
The main purposes of the study are to compare changes in sexual function, changes in sex hormones, and changes in body image and marital satisfaction at 12, 24, 36 and 48 months postoperatively in two groups: individuals who undergo a bariatric surgical procedure and extremely obese individuals with similar… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric surgery and lifestyle intervention (behavioral weight loss)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Sep 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age: Patients must be between 18 and 65 years of age.
- Gender: Both women and men are eligible to participate.
- Ethnicity and Race: Individuals from all ethnic and racial groups will be invited to participate.
- Body Mass Index: 40 to 60 kg/m2 (or of > 35 kg/m2 in the presence of co-morbid medical conditions).
- Ambulation: Patients must be ambulatory, given the frequent number of assessments (and difficult arranging transportation for non-ambulatory individuals
- Competent: The patient must be able to communicate with the investigator and be legally competent, provide written informed consent.
Who cannot join
- • Any major illnesses that the surgical team believes present too great a risk for surgery. These include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.
- Evidence of major depression or other psychiatric disorder (schizophrenia, bipolar disorder, major depression, bulimia nervosa, etc.) that significantly interferes with daily living and functioning.
- Use of medications known to significantly increase body weight, such as systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and anti-psychotic agents (The use of selective serotonin re-uptake inhibitors (SSRIs) will not be excluded because of their widespread use and lesser effect on body weight.)
- Patients who are not in an ongoing romantic relationship
- Any current (past 12 months) substance abuse or dependence disorder.
- Pregnancy or lactation (Those who are pregnant do not undergo bariatric surgery. In addition, the hormone changes induced by pregnancy are known to interfere with the hormones examined in this study, confounding the findings. Participants who become pregnant while in this study will be withdrawn from the study.)
About this study
Official title: Psychosocial Changes Associated With Weight Loss
The main purposes of the study are to compare changes in sexual function, changes in sex hormones, and changes in body image and marital satisfaction at 12, 24, 36 and 48 months postoperatively in two groups: individuals who undergo a bariatric surgical procedure and extremely obese individuals with similar obesity-related comorbidities who do not seek surgery (treatment comparison group).
The mechanisms by which extreme obesity affects sexual functioning have received little attention. Recent epidemiologic studies suggest that obesity and physical inactivity are independently related to the likelihood of developing sexual dysfunction over time. For example, men with a BMI greater than 29 kg/m2 have a 30% greater risk of developing erectile dysfunction and up to 50 % of ED cases can be attributed to hypertension and cardiovascular disease, both commonly associated with obesity. Many treatments for hypertension have also been shown to interfere with sexual function.
Read more
Changes in sex hormones with increasing BMI have not received much attention either. Obesity has been associated with decreases in testosterone and sex hormone binding globulin for men and increases in testosterone and estrogen for women. Several studies have shown improvement in sex hormone levels in both men and women following weight loss. Sexual functioning has never been assessed in association with weight loss and whether through improvements in body image, sex hormones, or obesity related comorbidities, bariatric surgery may have a profound effect on sexual functioning.
Dr. Ray Rosen, the Principal investigator for this sub study, has conducted a previous investigation focused on sexual functioning after weight loss in a behavioral weight loss program. Specifically, he looked at short and long term sexual function outcomes associated with Type-2 diabetes. His previous work in this area has shown that patients are willing to participate in studies of sexual function.
The Psychosocial Changes study assesses sexual function in two ways. Participants first fill out a packet of questionnaires covering topics related to depression, quality of life, body image, and marital and sexual functioning. They also give a blood sample in order for us to assess levels of sex hormones including testosterone, luteinizing hormone, estradiol, follicle stimulating hormone, and others.
- Conditions
- Obesity
- Being tested
- Bariatric surgery, lifestyle intervention (behavioral weight loss)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
patients receive either gastric bypass or lap-band
lifestyle intervention (behavioral weight loss)Behavioural
participants attend biweekly weight loss counseling group sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Bariatric surgery |
| 2 | Experimental | Not described Receives: Behavioral: lifestyle intervention (behavioral weight loss) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual functioning as measured by the International Index for Erectile Dysfunction (for men) and the Female Sexual Function Inventory (for women)
Measured: 48 months
Secondary outcomes (4)
sex hormones
Measured: 48 months
body image (Body Shape Questionnaire and The Body Image Quality of Life Questionnaire)
Measured: 48 months
relationship functioning (Dyadic Adjustment Scale)
Measured: 48 months
quality of life (Impact of Weight on Quality of Life questionnaire and Medical Short Form Survey)
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startAug 2005
- Primary completionOct 2007
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670098
- Sponsor's protocol ID
- DK72452
- Other IDs
- R01DK072452
- Status last verified
- Nov 2011
- First submitted
- 30 Apr 2008
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24190440
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Changes Associated With Weight Loss
- ClinicalTrials.gov ID
- NCT00670098
- Acronym / sponsor ID
- DK72452
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 May 2008 (estimated)
- 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 main purposes of the study are to compare changes in sexual function, changes in sex hormones, and changes in body image and marital satisfaction at 12, 24, 36 and 48 months postoperatively in two groups: individuals who undergo a bariatric surgical procedure and extremely obese individuals with similar obesity-related comorbidities who do not seek surgery (treatment comparison group).
The mechanisms by which extreme obesity affects sexual functioning have received little attention. Recent epidemiologic studies suggest that obesity and physical inactivity are independently related to the likelihood of developing sexual dysfunction over time. For example, men with a BMI greater than 29 kg/m2 have a 30% greater risk of developing erectile dysfunction and up to 50 % of ED cases can be attributed to hypertension and cardiovascular disease, both commonly associated with obesity. Many treatments for hypertension have also been shown to interfere with sexual function.
Changes in sex hormones with increasing BMI have not received much attention either. Obesity has been associated with decreases in testosterone and sex hormone binding globulin for men and increases in testosterone and estrogen for women. Several studies have shown improvement in sex hormone levels in both men and women following weight loss. Sexual functioning has never been assessed in association with weight loss and whether through improvements in body image, sex hormones, or obesity related comorbidities, bariatric surgery may have a profound effect on sexual functioning.
Dr. Ray Rosen, the Principal investigator for this sub study, has conducted a previous investigation focused on sexual functioning after weight loss in a behavioral weight loss program. Specifically, he looked at short and long term sexual function outcomes associated with Type-2 diabetes. His previous work in this area has shown that patients are willing to participate in studies of sexual function.
The Psychosocial Changes study assesses sexual function in two ways. Participants first fill out a packet of questionnaires covering topics related to depression, quality of life, body image, and marital and sexual functioning. They also give a blood sample in order for us to assess levels of sex hormones including testosterone, luteinizing hormone, estradiol, follicle stimulating hormone, and others.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Bariatric surgery |
| 2 | Experimental | Behavioral: lifestyle intervention (behavioral weight loss) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Age: Patients must be between 18 and 65 years of age.
Key exclusion criteria (6 listed)
- • Any major illnesses that the surgical team believes present too great a risk for surgery. These include severe cardiac and pulmonary diseases, as well as uncontrolled type 2 diabetes.
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 |
|---|---|---|
| Bariatric surgerypatients receive either gastric bypass or lap-band | Procedure or surgery | 1 |
| lifestyle intervention (behavioral weight loss)participants attend biweekly weight loss counseling group sessions | Behavioural | 2 |
Primary outcome
Sexual functioning as measured by the International Index for Erectile Dysfunction (for men) and the Female Sexual Function Inventory (for women)
Time frame: 48 months
4 secondary outcomes
sex hormones
Time frame: 48 months
body image (Body Shape Questionnaire and The Body Image Quality of Life Questionnaire)
Time frame: 48 months
relationship functioning (Dyadic Adjustment Scale)
Time frame: 48 months
quality of life (Impact of Weight on Quality of Life questionnaire and Medical Short Form Survey)
Time frame: 48 months
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 22 Oct 2015.
- Derived from this study: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery and lifestyle intervention (behavioral weight loss) in people with Obesity, run by University of Pennsylvania.
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 6 inclusion and 6 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 22 Oct 2015. 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?
Sexual functioning as measured by the International Index for Erectile Dysfunction (for men) and the Female Sexual Function Inventory (for women) (time frame: 48 months). 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 NCT00670098, which also lists 1 linked publication.
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 22 Oct 2015.