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

NCT02004561 | Active Not Recruiting

• 2 other identifiers: 11090090342R01HD028016-20A1
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Adolescents

Keywords

bariatric_surgery; pediatric obesity; diabetes

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

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-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
• 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

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Yale Pediatric Endocrinology Clinic

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sonia Caprio, MD

  Yale University

  PRINCIPAL INVESTIGATOR

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 1, 2012
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)