Metabolic Factors of Outcomes From Gastric Bypass Surgery (Cassini)
This study has been terminated.
(Study was terminated for business reasons.)
Sponsor:
Ethicon Endo-Surgery
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
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Results First Received: April 19, 2012
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Case-Only; Time Perspective: Prospective |
| Condition: |
Obesity |
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
| 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
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
| 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 ] |
Hide Outcome Measure 5| Measure Type | Secondary |
|---|---|
| Measure Title | Adiponectin and Lectin |
| Measure Description | These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10. |
| Time Frame | 16 months |
| Safety Issue | No |
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. |
Measured Values
| All Subjects | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
0 |
|
Adiponectin and Lectin
[units: units on a scale] |
No statistical analysis provided for Adiponectin and Lectin
| 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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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
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 |