The Development of an Eating Laboratory for Overweight Adolescents
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|ClinicalTrials.gov Identifier: NCT00764127|
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : January 31, 2013
|Condition or disease|
The purpose of this study is to examine the eating behavior, meal-related perceptions and meal-related hormones in overweight adolescents, normal weight adolescents and overweight adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will be taken before, during, and after the meal to assess hormonal responses to the meal. The multiple-item meal will permit an assessment of total caloric consumption, food and macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their surgery. Some bariatric surgery patients will only be studied after their after their surgery.
The data gathered from these pilot subjects will be used to further develop and refine our future studies on assessing eating behavior in overweight adolescents.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Observational Model:||Case Control|
|Official Title:||The Development of an Eating Laboratory for Overweight Adolescents|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY|
- Caloric intake [ Time Frame: post-meal ]
Biospecimen Retention: Samples Without DNA
10 cc (2 teaspoons) of blood will be drawn during the screening assessment to screen for medical illness.
60 cc (12 teaspoons) of blood will be drawn from an indwelling IV catheter during the single-item meal to assay for meal-related hormones (ghrelin, leptin,cholecystokinin, insulin, peptideY). Bariatric surgery participants may have an additional 20 cc of blood taken to measure glucose responses to the meal.
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): NCT00764127
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Michael Devlin, M.D.||New York State Psychiatric Institute|