We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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: NCT00998374
Recruitment Status : Completed
First Posted : October 20, 2009
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
Medtronic - MITG

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Hypoglycemia

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 39   23   62 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   39   23   62 
>=65 years   0   0   0 
[Units: Participants]
Female   24   20   44 
Male   15   3   18 
Region of Enrollment 
[Units: Participants]
United States   39   23   62 

  Outcome Measures

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

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
No text entered.

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

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00998374     History of Changes
Other Study ID Numbers: AS08018
First Submitted: October 15, 2009
First Posted: October 20, 2009
Results First Submitted: January 27, 2014
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014