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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Low glycemic load diet | Outpatient behavioral counseling |
| BEHAVIORAL | Low fat diet | Outpatient 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.