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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480922
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : August 26, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatic Steatosis Behavioral: Low glycemic load diet Behavioral: Low fat diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
A low glycemic load diet
Behavioral: Low glycemic load diet
Outpatient behavioral counseling

Active Comparator: 2
Low fat diet
Behavioral: Low fat diet
Outpatient behavioral counseling

Primary Outcome Measures :
  1. percent liver fat as determined by nMR spectroscopy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. hepatic steatosis as measured by T1 weighted MRI images [ Time Frame: 6 monhts ]
  2. visceral fat [ Time Frame: 6 months ]
  3. liver function tests [ Time Frame: 6 months ]
  4. measures of oxidative stress [ Time Frame: 6 months ]
  5. measures of chronic inflammation [ Time Frame: 6 months ]
  6. insulin resistance [ Time Frame: 6 months ]
  7. serum lipids [ Time Frame: 6 months ]
  8. blood pressure [ Time Frame: 6 months ]
  9. insulin secretion [ Time Frame: baseline ]
  10. measures of glucose tolerance [ Time Frame: 6 months ]
  11. adiponectin [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480922

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United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
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Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boston Children’s Hospital Identifier: NCT00480922     History of Changes
Other Study ID Numbers: 07-03-0092 (completed)
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Boston Children’s Hospital:
non-alcoholic fatty liver disease
insulin resistance

Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases