The Development of an Eating Laboratory for Overweight Adolescents
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Purpose
The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery.
| Condition |
|---|
|
Adolescent Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Development of an Eating Laboratory for Overweight Adolescents |
- Caloric intake [ Time Frame: post-meal ] [ Designated as safety issue: No ]
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.
| Enrollment: | 36 |
| Study Start Date: | February 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Obese Control |
| Normal Control |
| OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
community sample
Inclusion Criteria:
- BMI Index Enrollment in bariatric surgery program Ages 12-18
Exclusion Criteria:
- Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00764127 History of Changes |
| Other Study ID Numbers: | #5217 DK074503-01, R21DK074503 |
| Study First Received: | September 30, 2008 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York State Psychiatric Institute:
|
adolescent obesity bariatric surgery eating |
Additional relevant MeSH terms:
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013