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NCT02412540 · ClinicalTrials.gov registry record · NA
Controlled Trial of WLS vs. CLI for Severely Obese Adolescents With NASH
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT02412540: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02412540 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02412540, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study 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.
Primary Outcome
Proportion of subjects achieving greater than 2 point reduction in NASH activity score (NAS) across at least two separate histological components of the NAS score (steatosis, inflammation and ballooning) and no worsening of fibrosis stage.
Interventions
- BEHAVIORAL Comprehensive Lifestyle Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2015-04-23 |
| Est. Completion | 2021-03-02 |
| Phase | NA |
What the finished NCT02412540 record still lists
NCT02412540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Comprehensive Lifestyle Intervention is the first listed.
NCT02412540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02412540 about?
NCT02412540 is a clinical study titled "Controlled Trial of WLS vs. CLI for Severely Obese Adolescents With NASH". 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. Peop...
What is the current status of trial NCT02412540?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2015-04-23. Estimated completion is 2021-03-02.
What interventions are being tested in trial NCT02412540?
The interventions under investigation include: Comprehensive Lifestyle Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02412540?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02412540's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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