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

Boston Children's Hospital

Status: Completed

Conditions: Hepatic Steatosis

Treatments: Behavioral: Low fat diet; Behavioral: Low glycemic load diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00480922

07-03-0092 (completed)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

A low glycemic load diet

Treatment:

Behavioral: Low glycemic load diet

2

Active Comparator group

Description:

Low fat diet

Treatment:

Behavioral: Low fat diet