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

Completed · Not applicable

Conditions studied: Hepatic Steatosis

In brief

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.

Key facts

Study ID

NCT00480922

Run by

Boston Children's Hospital

People needed

40

Starts

2007-05-01

Expected to finish

2009-12-01

Last updated by the study team

2011-08-26

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI >95th percentile for age and sex
• Weight <300 pounds
• Ability to lie quietly in the MRI for approximately 45 minutes
• Willing and able to attend all sessions.
• Working telephone
• Greater than or equal to 10% hepatic steatosis on nMR spectroscopy

You may not qualify if…

• Any other medical condition besides obesity that may predispose to liver disease
• Medications that affect liver metabolism
• Any causes of chronic hepatitis
• Diabetes
• Inability to adhere to prescribed diets
• Currently on high-dose vitamins and not willing to discontinue
• Weight loss/gain in the past 6 months of >10% of total body weight.
• Sibling of any subject who is already enrolled
• Any alcohol consumption

Where it is running

• Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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