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

Hepatic Steatosis Clinical Trial

— DELIVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480922
• Other study ID #: 07-03-0092 (completed)
• Status: Completed
• Phase: N/A
• First received: May 23, 2007
• Last updated: August 25, 2011
• Start date: May 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis

Intervention

Behavioral:
• Low glycemic load diet
Outpatient behavioral counseling
• Low fat diet
Outpatient behavioral counseling

Locations

Country	Name	City	State
United States	Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

References & Publications (1)

Scribner KB, Pawlak DB, Ludwig DS. Hepatic steatosis and increased adiposity in mice consuming rapidly vs. slowly absorbed carbohydrate. Obesity (Silver Spring). 2007 Sep;15(9):2190-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent liver fat as determined by nMR spectroscopy		6 months	No
Secondary	hepatic steatosis as measured by T1 weighted MRI images		6 monhts	No
Secondary	visceral fat		6 months	No
Secondary	liver function tests		6 months	No
Secondary	measures of oxidative stress		6 months	No
Secondary	measures of chronic inflammation		6 months	No
Secondary	insulin resistance		6 months	No
Secondary	serum lipids		6 months	No
Secondary	blood pressure		6 months	No
Secondary	insulin secretion		baseline	No
Secondary	measures of glucose tolerance		6 months	No
Secondary	adiponectin		6 months	No