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The Development of an Eating Laboratory for Overweight Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00764127
First received: September 30, 2008
Last updated: January 30, 2013
Last verified: January 2013

September 30, 2008
January 30, 2013
February 2008
November 2010   (final data collection date for primary outcome measure)
Caloric intake [ Time Frame: post-meal ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764127 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Development of an Eating Laboratory for Overweight Adolescents
The Development of an Eating Laboratory for Overweight Adolescents

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

community sample

Adolescent Obesity
Not Provided
  • Obese Control
  • Normal Control
  • OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00764127
#5217 DK074503-01, R21DK074503
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Michael Devlin, M.D. New York State Psychiatric Institute
New York State Psychiatric Institute
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP