Clinical Trials Directory

Trials / Completed

CompletedNCT00480922

Effects of a Low Glycemic Load Diet on Fatty Liver in Children

Randomized Controlled Trial Comparing the Effects of a Low Glycemic Load Diet With a Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescents

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Boston Children's Hospital · Academic / Other
Sex
All
Age
8 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLow glycemic load dietOutpatient behavioral counseling
BEHAVIORALLow fat dietOutpatient behavioral counseling

Timeline

Start date
2007-05-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2007-05-31
Last updated
2011-08-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00480922. Inclusion in this directory is not an endorsement.