Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of a Low Glycemic Load Diet on Fatty Liver in Children (DELIVER)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), November 2008
Sponsored by: Children's Hospital Boston
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00480922
  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

MedlinePlus related topics: Liver Diseases
Drug Information available for: Insulin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
A low glycemic load diet
Behavioral: Low glycemic load diet
Outpatient behavioral counseling
2: Active Comparator
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

Contacts
Contact: Sandra Salsberg, MD 617 355-7703 sandra.salsberg@childrens.harvard.edu

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

Related Info  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Children's Hospital Boston ( David Ludwig, MD, PhD )
Study ID Numbers: 07-03-0092
Study First Received: May 23, 2007
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00480922  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
non-alcoholic fatty liver disease
steatohepatitis
overweight
insulin resistance

Study placed in the following topic categories:
Liver Diseases
Non-alcoholic steatohepatitis (NASH)
Digestive System Diseases
Overweight
Fatty Liver
Insulin Resistance
Insulin

ClinicalTrials.gov processed this record on January 13, 2009