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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Steatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

A low glycemic load diet

Group Type EXPERIMENTAL

Low glycemic load diet

Intervention Type BEHAVIORAL

Outpatient behavioral counseling

2

Low fat diet

Group Type ACTIVE_COMPARATOR

Low fat diet

Intervention Type BEHAVIORAL

Outpatient behavioral counseling

Interventions

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Low glycemic load diet

Outpatient behavioral counseling

Intervention Type BEHAVIORAL

Low fat diet

Outpatient behavioral counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No