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Obese AdolescentsNCT02004561

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

An observational study of Obese Adolescents, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 19 years
Conditions the study is for
Obese Adolescents
How many people
26 participants
Where
1 siteUnited States
Study dates
Jan 2012to Aug 2026
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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
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  • Capability and willingness to adhere to nutritional guidelines postoperatively
  • Informed consent to surgical treatment
  • Demonstration of decisional capacity
  • Supportive family environment

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale Pediatric Endocrinology Clinic

    New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Outcomes Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, and Gastric Bypass Surgeries in Obese Adolescents

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.

Read the detailed description

Twenty-six obese adolescents with plans to undergo bariatric surgery for clinical treatment will be recruited for research study during screening process at the Yale Adolescent Bariatric Surgery Clinic. After the appropriate discussion with surgeon, the choice of procedure will be made by subject and legal guardian.

Every bariatric patient must have completed the thorough six-month evaluation period established by the Yale's Adolescent Bariatric Clinic.

This standard of care pre-operative testing provides as a screening tool to ensure every adolescent bariatric patient is mentally and physically appropriate for this surgery.

  • Monthly visits with clinician (Pediatric Obesity/Diabetology Expert) and dietician to discuss lifestyle change management and anthropometric measures.
  • Psychiatrist or psychologist to screen for depression, uncontrollable psychosis, suicidal ideation, and hostile or unsupportive family environment.
  • Bone age will be obtained to ensure subject has reached or near full growth potential.
  • Pediatric Cardiology for echocardiogram to rule out left ventricular hypertrophy.
  • Oral glucose tolerance test to assess glucose status and degree of insulin resistance.
  • Blood work to assess hepatic and kidney function, nutritional deficiencies, hormonal profile, and hyperlipidemia.
  • Pediatric Pulmonary for sleep study and Pulmonary Function Tests (PFTs) to rule out obstructive sleep apnea.

When a subject is approved for surgery, he or she will meet with Bariatric Surgeon to discuss benefits and risks of each bariatric surgery. After the appropriate discussion with surgeon, the choice of procedure will be made by subject and legal guardian. For research purposes, we seek to monitor the progress of the patients enrolled in Yale's Adolescent Bariatric Surgery Clinic. Collecting pre and post long term operative data will allow us to describe this efficacy and potential complications that arise with RYGB vs LAGB.

As standard of care, all subjects will have undergone pre-operative testing established by Adolescent Bariatric Surgery Clinic before any of the bariatric surgeries.

For research purposes:

  1. Month prior to Surgery
  • Oral Glucose Tolerance Test (OGTT)
  • Abdominal MRI (weight must not exceed 140 kg)
  • DNA blood extraction During RYGB or LAGB Surgery
  • Liver Biopsy
  • Visceral (omental fat) and Subcutaneous Fat Biopsy Data collection will continue for 24 months post-operatively and include both research testing and standard of care clinical appointments. Post Surgery 2 week 2 months 3 months 6 months 12 months 24 months Standard Of Care Post-op Post-op Post-op Post-op Post-op Post-op Anthropometric X X X X X X Measures Hemoglobin A1c X X X X X
  1. Week 2 Month 3 Month 6 Month 12 Month 24 Month Post Surgery (research) Post-op Post-op Post-op Post-op Post-op Post-op OGTT X X X Abdominal MRI X X X X X X

Anthropometric Measures and HBA1c Anthropometric measures will be done at study enrollment, monthly leading up to the surgery RYGB or LAGB, and 2 weeks, 2 months, 3 months, 6 months, 12 months and 24 months post operatively. These measures include height, weight, BMI, BMI Z score, systolic and diastolic blood pressure, resting heart rate, % fat mass, and total fat mass. Demographic data includes ethnicity and family income. HbA1c will be completed at the 3, 6 , 12, and 24 month post operative time period.

Keywords
bariatric_surgery, pediatric obesity, diabetes
Medical subject headings
Pediatric Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02004561
Study groupRoleWhat they receive
Gastric BandingPatients chose Gastric banding
Gastric BypassPatients chose gastric bypass surgical operation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glucose Tolerance

    Glucose tolerance changes measured by 3 hour oral glucose tolerance test.

    Measured: baseline, 2 month, 3 month, 12 month

Secondary outcomes (2)
  1. Change in Anthropometric data

    Height, weight, body fat percentage changes

    Measured: Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months

  2. Changes in nutritional health

    Changes in vitamin/mineral blood levels

    Measured: Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionAug 2026
  4. Study completionAug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
26 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02004561
Sponsor's protocol ID
1109009034
Other IDs
2R01HD028016-20A1
Status last verified
Oct 2026
First submitted
11 Nov 2013
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obese Adolescents, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glucose Tolerance (time frame: baseline, 2 month, 3 month, 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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