Status:
COMPLETED
Changes in Sexual Function Following Bariatric Surgery
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- • 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.
Exclusion
- • 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 Participants who become pregnant while in this study will be withdrawn from the study.)
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00670098
Start Date
August 1 2005
End Date
September 1 2013
Last Update
October 22 2015
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