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

Study Overview
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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.

Official Title
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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

Conditions
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Hepatic Steatosis

Intervention / Treatment
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* Behavioral: Low glycemic load diet
* Behavioral: Low fat diet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>A low glycemic load diet | Behavioral: Low glycemic load diet<br>* Outpatient behavioral counseling<br>|
| Active Comparator: 2<br>Low fat diet | Behavioral: Low fat diet<br>* Outpatient behavioral counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent liver fat as determined by nMR spectroscopy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-alcoholic fatty liver disease, steatohepatitis, overweight, insulin resistance