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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00480922
First received: May 23, 2007
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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 Intervention
Hepatic Steatosis
Behavioral: Low glycemic load diet
Behavioral: Low fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • percent liver fat as determined by nMR spectroscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hepatic steatosis as measured by T1 weighted MRI images [ Time Frame: 6 monhts ] [ Designated as safety issue: No ]
  • visceral fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • liver function tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • measures of oxidative stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • measures of chronic inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • insulin resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • serum lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • insulin secretion [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • measures of glucose tolerance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • adiponectin [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480922

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00480922     History of Changes
Other Study ID Numbers: 07-03-0092 (completed)
Study First Received: May 23, 2007
Last Updated: August 25, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 17, 2014