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Taste Perception Pre and Post Bariatric Surgery (RBtaste)

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ClinicalTrials.gov Identifier: NCT01536197
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : July 3, 2014
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Morbid Obesity
Interventions: Procedure: Gastric bypass
Procedure: Gastric banding
Procedure: Sleeve gastrectomy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gastric Bypass

morbidly obese subjects undergoing gastric bypass surgery

Gastric bypass: Roux-en-Y gastric bypass

Gastric Banding

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Gastric banding: Laparoscopic adjustable gastric banding


Participant Flow:   Overall Study
    Gastric Bypass   Gastric Banding
STARTED   23   10 
COMPLETED   23   10 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gastric Bypass

morbidly obese subjects undergoing gastric bypass surgery

Gastric bypass: Roux-en-Y gastric bypass

Gastric Banding

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Gastric banding: Laparoscopic adjustable gastric banding

Total Total of all reporting groups

Baseline Measures
   Gastric Bypass   Gastric Banding   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   10   33 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.0  (9.6)   46.8  (13.9)   43.5  (10.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  87.0%      10 100.0%      30  90.9% 
Male      3  13.0%      0   0.0%      3   9.1% 
Body weight before surgery 
[Units: Kg]
Mean (Standard Deviation)
 129.8  (26.1)   127.1  (31.0)   128.7  (27.2) 


  Outcome Measures

1.  Primary:   Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).   [ Time Frame: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery ]

2.  Secondary:   Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).   [ Time Frame: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: M. Yanina Pepino
Organization: University of Illinois at Urbana Champaign
phone: 217-300-2374
e-mail: ypepino@illinois.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01536197     History of Changes
Other Study ID Numbers: 09-0175B
First Submitted: February 9, 2012
First Posted: February 20, 2012
Results First Submitted: June 2, 2014
Results First Posted: July 3, 2014
Last Update Posted: December 18, 2017