N/A
Completed N=137
LAGB as a Treatment for Morbid Obesity in Adolescents
Source: ClinicalTrials.gov NCT01045499 ↗Enrolled (actual)
137
Serious AEs
46.0%
Results posted
Apr 2020
Primary outcomePrimary: Percentage of Excess Weight Change (EWL) — -35.5 percent change
Summary
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Excess Weight Change (EWL) |
-35.5 | — |
| SECONDARY Percentage of Excess BMI Change |
36.6 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 13-17 upon entry
- BMI >40 or >35 with associated medical comorbidities (e.g., sleep apnea, hypertension
Exclusion Criteria
- severe psychiatric illness
- eating disorder with purging
- previous weight loss surgery
- stated inability to comply with pre-op and post-op visits
Data sourced from ClinicalTrials.gov (NCT01045499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.