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Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity (SexOb)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528980
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date April 25, 2018
First Posted Date May 18, 2018
Last Update Posted Date October 11, 2019
Study Start Date May 2012
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2018)
Improvement of sexual function assessed by International Index for Erectile Dysfunction (IIED) [ Time Frame: at 1 year ]
This questionnaire consists of 15 questions addressing the following topics: erectile function, orgasmic function, sexual desire, satisfaction of the sexual relation, satisfaction of the relationship in general. Each question is scored from 0 to 5. All responses are scored between 0 and 75. Sexual function is considered normal if the IIED score is greater than 25
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2018)
  • Percentage of patients with normal sexual function (IIED> 25) with and without surgery. [ Time Frame: ay 1 year ]
  • Change the spermatic parameters before and after weight loss in both groups [ Time Frame: at 1 year and 2 years ]
  • Change the serum profile of sex hormones before and after weight loss in both groups a [ Time Frame: at 1 year ]
  • Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery [ Time Frame: at 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity
Official Title Comparing the Impact of Weight Loss Induced by Bariatric Surgery or Through a Standard Nutritional Management on Sexual Function and Sperm Quality in Men With Severe Obesity - Multicenter, Prospective
Brief Summary Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with morbid obesity,
Condition
  • Obesity
  • Bariatric Surgery Candidate
Intervention Not Provided
Study Groups/Cohorts
  • Bariatric surgery
  • standard nutritional management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 17, 2018)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Severe obesity with BMI> 25 kg / m2

Exclusion Criteria:

  • Patient having undergone sterilization
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03528980
Other Study ID Numbers 2011_07
2011-A01012-39 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Ministry of Health, France
Investigators
Principal Investigator: Robert Caiazzo, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date October 2019