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Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00998374
First received: October 15, 2009
Last updated: March 19, 2014
Last verified: March 2014
Results First Received: January 27, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Hypoglycemia
Obesity

  Participant Flow
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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
Pyloric-sparing Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS)
Non-pyloric Sparing Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)

Participant Flow:   Overall Study
    Pyloric-sparing     Non-pyloric Sparing  
STARTED     39     23  
COMPLETED     27     12  
NOT COMPLETED     12     11  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Pyloric-sparing Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch
Non-pyloric Sparing Non-pyloric sparing: Roux-en-Y Gastric Bypass
Total Total of all reporting groups

Baseline Measures
    Pyloric-sparing     Non-pyloric Sparing     Total  
Number of Participants  
[units: participants]
  39     23     62  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     39     23     62  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     24     20     44  
Male     15     3     18  
Region of Enrollment  
[units: participants]
     
United States     39     23     62  



  Outcome Measures
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1.  Primary:   Mean Serum Glucose Levels   [ Time Frame: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively ]

2.  Primary:   Reactive Hypoglycemia Status   [ Time Frame: 6 months, 9 months, 12 months post-op ]

3.  Secondary:   Insulin Resistance   [ Time Frame: 6, 9, and 12 months post-operatively ]

4.  Secondary:   Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing   [ Time Frame: 6, 9, and 12 months post-op ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Dr. Mitchell Roslin
Organization: Lenox Hill Hospital
phone: 212-434-3285
e-mail: MRoslin@NSHS.edu


No publications provided


Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT00998374     History of Changes
Other Study ID Numbers: AS08018
Study First Received: October 15, 2009
Results First Received: January 27, 2014
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board