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

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ClinicalTrials.gov Identifier: NCT03528980
Recruitment Status : Terminated (default inclusion)
First Posted : May 18, 2018
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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

Condition or disease
Obesity Bariatric Surgery Candidate

Study Design
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : May 2012
Actual Primary Completion Date : January 2021
Actual Study Completion Date : January 2021

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Groups and Cohorts
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Group/Cohort
Bariatric surgery
standard nutritional management


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of patients with normal sexual function (IIED> 25) with and without surgery. [ Time Frame: ay 1 year ]
  2. Change the spermatic parameters before and after weight loss in both groups [ Time Frame: at 1 year and 2 years ]
  3. Change the serum profile of sex hormones before and after weight loss in both groups a [ Time Frame: at 1 year ]
  4. Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery [ Time Frame: at 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with morbid obesity,
Criteria

Inclusion Criteria:

  • Severe obesity with BMI> 25 kg / m2

Exclusion Criteria:

  • Patient having undergone sterilization
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528980


Locations
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France
Chu de Caen Normandie
Caen, France
CHRU, Hôpital Claude Huriez
Lille, France
Chu Rouen
Rouen, France
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Principal Investigator: Robert Caiazzo, MD, PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03528980    
Other Study ID Numbers: 2011_07
2011-A01012-39 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
fertility
bariatric surgery
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Weight Loss
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Body Weight Changes