Metabolic Factors of Outcomes From Gastric Bypass Surgery (Cassini)

This study has been terminated.
(Study was terminated for business reasons.)
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01347840
First received: May 3, 2011
Last updated: April 19, 2012
Last verified: April 2012
Results First Received: April 19, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: 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
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
  Description
All Subjects This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.

Participant Flow:   Overall Study
    All Subjects  
STARTED     1 [1]
COMPLETED     0  
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] 1 subject enrolled but withdrew consent



  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.
No text entered.

Reporting Groups
  Description
All Subjects This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.

Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  51  ± 0  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures
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1.  Primary:   Percent Excess Weight Loss   [ Time Frame: 16 months ]

2.  Primary:   Resting Energy Expenditure   [ Time Frame: 16 months ]

3.  Primary:   Area Under the Curve of Ghrelin and GLP-1   [ Time Frame: 16 months ]

4.  Secondary:   Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)   [ Time Frame: 16 months ]

5.  Secondary:   Adiponectin and Lectin   [ Time Frame: 16 months ]

6.  Secondary:   Subject Questionnaires   [ Time Frame: 16 months ]

7.  Secondary:   Area Under the Curve of Glucose   [ Time Frame: 16 months ]

8.  Secondary:   Hemoglobin A1c and Lipid Panel   [ Time Frame: 16 months ]

9.  Secondary:   Body Mass Index   [ Time Frame: 16 Months ]

10.  Secondary:   Percent Weight Loss   [ Time Frame: 16 Months ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
Trial termination due to business needs. One subject enrolled and withdrew consent. Zero subjects completed study. No subject data analyzed.  


Results Point of Contact:  
Name/Title: Amy Mahanes
Organization: Ethicon Endo-Surgery, Inc.
phone: 513-337-8366
e-mail: amahanes@its.jnj.com


No publications provided


Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01347840     History of Changes
Other Study ID Numbers: CI-10-0004
Study First Received: May 3, 2011
Results First Received: April 19, 2012
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board