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

Not Applicable

Completed

• Conditions: Hepatic Steatosis
• Interventions: Behavioral: Low glycemic load diet; Behavioral: Low fat diet

• Registration Number: NCT00480922
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-29
• Study First Posted: 2007-05-31
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low glycemic load diet	A low glycemic load diet
2	Low fat diet	Low fat diet

Primary Outcome Measures

Name	Time	Method
percent liver fat as determined by nMR spectroscopy	6 months

Secondary Outcome Measures

Name	Time	Method
hepatic steatosis as measured by T1 weighted MRI images	6 monhts
visceral fat	6 months
liver function tests	6 months
measures of oxidative stress	6 months
measures of chronic inflammation	6 months
insulin resistance	6 months
serum lipids	6 months
blood pressure	6 months
insulin secretion	baseline
measures of glucose tolerance	6 months
adiponectin	6 months

Trial Locations

Locations (1)

Children's Hospital; 🇺🇸 Boston, Massachusetts, United States