NCT02412540

Controlled Trial of WLS vs. CLI for Severely Obese Adolescents With NASH

A Parallel Cohort Controlled Trial of Outcome of Nonalcoholic Steatohepatitis in Adolescents After Bariatric Surgery vs. Comprehensive Lifestyle Intervention (NASH ABC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine effective treatment and identify diagnostic biomarkers for Nonalcoholic steatohepatitis (NASH). Individuals that take part in the study will be participating in either a weight loss surgery (WLS) group or a comprehensive lifestyle intervention (CLI) group. People in the WLS group will receive vertical sleeve gastrectomy (VSG). The CLI group will receive dietary, activity and behavioral interventions provided by trained study staff.

Detailed description

The investigators have designed a rigorously controlled study designed to evaluate NASH outcomes in two parallel cohorts: 1) severely obese adolescents with NASH who have chosen to undergo WLS (specifically VSG) for clinical indications compared to 2) a control group of severely obese adolescents with NASH enrolled in a CLI offered as part of this study. The study will provide the best evidence to date of the effectiveness of WLS and CLI in treating NASH in adolescents with body mass index (BMI) ≥ 35 kg/m2. The investigators will also concurrently collect health-care utilization data to enable subsequent cost-effectiveness analyses (CEA) to evaluate the cost-effectiveness of WLS vs. CLI intervention in severely-obese adolescents with NASH. If the investigators' data support our hypothesis that WLS yields superior results, this will set the stage for randomized studies (if needed) and translational studies of weight loss-independent biological mechanism(s) unique to WLS, which may include specific changes in bile acid signaling and in the intestinal microbiome. The latter would facilitate developing novel pharmacotherapies accessible to younger or less obese children with NASH to whom WLS is not applicable. Cumulatively, this study has the potential to yield significant improvements in medical and quality of life (QOL) outcomes for a large proportion of pediatric patients with NASH and to reduce long term health care costs by identifying effective treatment options and decreasing progression to cirrhosis and end-stage liver disease.

Conditions

• Obesity
• Nonalcoholic Steatohepatitis
• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
BEHAVIORAL	Comprehensive Lifestyle Intervention	Dietary, behavioral and activity interventions designed to reduce weight.

Timeline

• Start date: 2015-04-23
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2015-04-09
• Last updated: 2021-11-02

Locations

1 site across 1 country: United States