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Metabolic Factors of Outcomes From Gastric Bypass Surgery (Cassini)

This study has been terminated.
(Study was terminated for business reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01347840
First Posted: May 4, 2011
Last Update Posted: May 21, 2012
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.
Information provided by (Responsible Party):
Ethicon Endo-Surgery
Results First Submitted: 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


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


  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: Amy Mahanes
Organization: Ethicon Endo-Surgery, Inc.
phone: 513-337-8366
e-mail: amahanes@its.jnj.com



Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01347840     History of Changes
Other Study ID Numbers: CI-10-0004
First Submitted: May 3, 2011
First Posted: May 4, 2011
Results First Submitted: April 19, 2012
Results First Posted: May 21, 2012
Last Update Posted: May 21, 2012