NCT00764127

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

September 30, 2008

Last Update Submit

January 30, 2013

Conditions

Adolescent Obesity

Keywords

adolescentobesitybariatric surgeryeating

Outcome Measures

Primary Outcomes (1)

  • Caloric intake

    post-meal

Study Arms (3)

Obese Control

Normal Control

OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • BMI Index Enrollment in bariatric surgery program Ages 12-18

You may not qualify if:

  • Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Sysko R, Devlin MJ, Schebendach J, Tanofsky-Kraff M, Zimmerli E, Korner J, Yanovski JA, Zitsman JL, Walsh BT. Hormonal responses and test meal intake among obese teenagers before and after laparoscopic adjustable gastric banding. Am J Clin Nutr. 2013 Nov;98(5):1151-61. doi: 10.3945/ajcn.113.061762. Epub 2013 Aug 28.

    PMID: 23985807DERIVED

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.

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Devlin, M.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

February 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)