Metabolic Factors of Outcomes From Gastric Bypass Surgery (Cassini)
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|ClinicalTrials.gov Identifier: NCT01347840|
Recruitment Status : Terminated (Study was terminated for business reasons.)
First Posted : May 4, 2011
Results First Posted : May 21, 2012
Last Update Posted : May 21, 2012
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Metabolic Factors of Outcomes From Gastric Bypass Surgery|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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.
- Percent Excess Weight Loss [ Time Frame: 16 months ]Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.
- Resting Energy Expenditure [ Time Frame: 16 months ]Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.
- Area Under the Curve of Ghrelin and GLP-1 [ Time Frame: 16 months ]These variables will measure the combined effects of hormone concentration and duration.
- 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 ]These variables will measure the combined effects of hormone concentration and duration.
- Adiponectin and Lectin [ Time Frame: 16 months ]These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.
- Subject Questionnaires [ Time Frame: 16 months ]The subscales and total scores as set out in the scoring algorithms for Food Craving Inventory-II and Questionnaire on Craving for Sweet and Rich Foods will be presented.
- Area Under the Curve of Glucose [ Time Frame: 16 months ]This variable will measure the combined effects of glucose concentration and duration.
- Hemoglobin A1c and Lipid Panel [ Time Frame: 16 months ]These laboratory values will be collected at Screening, Visit 8, and Visit 10.
- Body Mass Index [ Time Frame: 16 Months ]Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.
- Percent Weight Loss [ Time Frame: 16 Months ](Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347840
|United States, Ohio|
|Veterans Affairs Medical Center|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||David D'Alessio, MD||Veterans Affairs Medical Center, Cincinnati, OH|