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

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ClinicalTrials.gov Identifier: NCT02004561
Recruitment Status : Recruiting
First Posted : December 9, 2013
Last Update Posted : April 27, 2017
Sponsor:
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

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

Group/Cohort
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



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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02004561


Contacts
Contact: Jessica Nouws, PhD 203-785-6972 jessica.nouws@yale.edu
Contact: Bridget Pierpont, MA 23-785-2942 bridget.pierpont@yale.edu

Locations
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
Investigators
Principal Investigator: Sonia Caprio, MD Yale University

Responsible Party: Sonia Caprio, Professor, Yale University
ClinicalTrials.gov 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:
bariatric_surgery
pediatric obesity
diabetes