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NCT00480922 · ClinicalTrials.gov registry record · NA
Effects of a Low Glycemic Load Diet on Fatty Liver in Children
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT00480922: Completed NA study, sponsored by Boston Children's Hospital.
NCT00480922 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00480922, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
There has been a recent increase in incidence of obesity and its associated morbidities, including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case of pediatric hepatic steatosis was in 1980 and it is now affects 30-77% of overweight children. In addition to its association with obesity, hepatic steatosis has been associated with the metabolic syndrome, insulin resistance, and post-prandial hyperglycemia. Current treatment of hepatic steatosis includes weight loss with a hypocaloric low fat diet. Given the association with insulin resistance and post-prandial hyperglycemia, adult patients with hepatic steatosis that does not respond to weight loss are placed on insulin sensitizing drugs. We hypothesize that weight loss with a diet designed to decrease insulin resistance and post-prandial hyperglycemia, a low glycemic load diet, will provide a safe and effective way to decrease hepatic fat content in the pediatric population. This hypothesis will be tested with a randomized control trial comparing the effect of a low fat diet with a low glycemic load diet.
Interventions
- BEHAVIORAL Low fat diet
- BEHAVIORAL Low glycemic load diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-12 |
| Phase | NA |
What the finished NCT00480922 record still lists
NCT00480922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Low fat diet is the first listed.
NCT00480922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00480922 about?
NCT00480922 is a clinical study titled "Effects of a Low Glycemic Load Diet on Fatty Liver in Children". There has been a recent increase in incidence of obesity and its associated morbidities, including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case of pediatric hepatic steatosis...
What is the current status of trial NCT00480922?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2007-05. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00480922?
The interventions under investigation include: Low fat diet (BEHAVIORAL), Low glycemic load diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT00480922?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00480922's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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