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Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, Gastric Bypass Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02004561
Recruitment Status : Unknown
Verified April 2017 by Sonia Caprio, Yale University.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
Sonia Caprio, Yale University

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.

Condition or disease
Obese Adolescents

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Outcomes Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, and Gastric Bypass Surgeries in Obese Adolescents
Actual Study Start Date : January 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Gastric Banding
Patients chose Gastric banding
Gastric Bypass
Patients chose gastric bypass surgical operation

Primary Outcome Measures :
  1. Change in Glucose Tolerance [ Time Frame: baseline, 2 month, 3 month, 12 month ]
    Glucose tolerance changes measured by 3 hour oral glucose tolerance test.

Secondary Outcome Measures :
  1. Change in Anthropometric data [ Time Frame: Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months ]
    Height, weight, body fat percentage changes

  2. Changes in nutritional health [ Time Frame: Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months ]
    Changes in vitamin/mineral blood levels

Other Outcome Measures:
  1. Fat distribution [ Time Frame: baseline, 2 weeks, 2 months, 3 months, 6 months, 12 months, 24 months ]
    Abdominal MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The research subjects will be recruited from the Yale Pediatric Obesity Clinic and the Endocrine Clinic.

Inclusion Criteria:

Youth 14-19yrs

  • 6 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02004561

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Contact: Jessica Nouws, PhD 203-785-6972
Contact: Bridget Pierpont, MA 23-785-2942

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United States, Connecticut
Yale Pediatric Endocrinology Clinic Recruiting
New Haven, Connecticut, United States, 06520
Contact: Melissa Shaw    203-785-6459      
Sponsors and Collaborators
Yale University
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Principal Investigator: Sonia Caprio, MD Yale University

Additional Information:

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Responsible Party: Sonia Caprio, Professor, Yale University Identifier: NCT02004561     History of Changes
Other Study ID Numbers: 1109009034
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sonia Caprio, Yale University:
pediatric obesity