NCT02004561

Completed

Comparison Between Gastric Band, Laparoscopic Sleeve Gastrec...

Yale University Source

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Other study identifiers

Sponsor study identifier

1109009034

Secondary identifiers

2R01HD028016-20A1

NIH

Study Type

observational

Actual enrollment (reported)

26

Locations

1 country

Sites

1

Timeline

Study Start

January 2012

Actual (reported)

Primary Completion

August 2026

Actual (reported)

Study Completion

August 2026

Actual (reported)

Brief Summary

Determine the short and long term safety and efficacy of the Gastric bypass , laparoscopic sleeve gastrectomy, and Gastric banding (LAGB) on severely obese adolescents. The procedure selection is made by the patient or patient and guardian. This is not a randomized trial.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 26 participants
Study completion date: August 2026
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2012
Actual (reported)
First Submitted
November 11, 2013
Actual (reported)
First Posted
December 9, 2013
Actual (reported)
Primary Completion
August 2026
Actual (reported)
Study Completion
August 2026
Actual (reported)

Last Updated: October 9, 2026
Status Verified: October 2026
Last Update Submitted: October 7, 2026

Conditions

Obese Adolescents

Keywords

bariatric_surgerypediatric obesitydiabetes

Outcome Measures

Primary Outcomes (1)

Change in Glucose Tolerance
Glucose tolerance changes measured by 3 hour oral glucose tolerance test.
baseline, 2 month, 3 month, 12 month

Secondary Outcomes (2)

Change in Anthropometric data
Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months
Changes in nutritional health
Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months

Other Outcomes (1)

Fat distribution
baseline, 2 weeks, 2 months, 3 months, 6 months, 12 months, 24 months

Study Arms (2)

Gastric Banding

Patients chose Gastric banding

Gastric Bypass

Patients chose gastric bypass surgical operation

Eligibility Criteria

Age14 Years - 19 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

The research subjects will be recruited from the Yale Pediatric Obesity Clinic and the Endocrine Clinic.

You may qualify if:

Youth 14-19yrs

Sponsors & Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIHcollaborator
Yale University
Otherlead

Study Sites (1)

Yale Pediatric Endocrinology Clinic

New Haven, Connecticut, 06520, United States

MeSH Terms

Conditions

Pediatric ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

Sonia Caprio, MD
Yale University
PRINCIPAL INVESTIGATOR

Enrollment

26 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 24 Months
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

December 9, 2013

Study Start

January 2012

Actual (reported)

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months of attempts at weight management by primary care physician or Pediatric Endocrinologist

Approval by the Adolescent Bariatric Surgery clinic to undergo surgery

Physically or nearly physically mature

BMI \>= 35kg/m2 with one obesity related comorbidities or BMI \>= 40 kg/m2

Commitment to avoid pregnancy for at least 1 year postoperatively

Capability and willingness to adhere to nutritional guidelines postoperatively

Informed consent to surgical treatment

Demonstration of decisional capacity

Supportive family environment

You may not qualify if:

Inability to be approved by Yale Adolescent Bariatric Surgery clinic to undergo surgery
Uncontrolled psychosis
Uncontrolled depression
Drug or alcohol abuse
History of congenital or acquired anomalies of gastrointestinal tract
Esophageal anatomical abnormality or dysmotility
Inflammatory bowel disease
Severe cardiopulmonary disease
Severe coagulopathy
Hepatic insufficiency or cirrhosis
Presence of localized or systemic infection at time of surgery
Obesity related to central causes: Prader Willi and hypothalamic abnormalities
Non-compliance to nutrition plan, exercise, and behavioral counseling/treatment
Pregnant, breast-feeding or planning of becoming pregnant within 1-2 years of surgery

Contact the study team to confirm eligibility.

Primary Completion

August 2026

Actual (reported)

Study Completion

August 2026

Actual (reported)

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02004561
Data provider: ClinicalTrials.gov
Source updated: 2026-10-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:10 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (2)

Gastric Banding

Gastric Bypass

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations