Effects of a Low Glycemic Load Diet on Fatty Liver in Children (DELIVER)
Primary Purpose
Hepatic Steatosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low glycemic load diet
Low fat diet
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Steatosis focused on measuring non-alcoholic fatty liver disease, steatohepatitis, overweight, insulin resistance
Eligibility 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
Sites / Locations
- Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
A low glycemic load diet
Low fat diet
Outcomes
Primary Outcome Measures
percent liver fat as determined by nMR spectroscopy
Secondary Outcome Measures
hepatic steatosis as measured by T1 weighted MRI images
visceral fat
liver function tests
measures of oxidative stress
measures of chronic inflammation
insulin resistance
serum lipids
blood pressure
insulin secretion
measures of glucose tolerance
adiponectin
Full Information
NCT ID
NCT00480922
First Posted
May 23, 2007
Last Updated
August 25, 2011
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00480922
Brief Title
Effects of a Low Glycemic Load Diet on Fatty Liver in Children
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Steatosis
Keywords
non-alcoholic fatty liver disease, steatohepatitis, overweight, insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
A low glycemic load diet
Arm Title
2
Arm Type
Active Comparator
Arm Description
Low fat diet
Intervention Type
Behavioral
Intervention Name(s)
Low glycemic load diet
Intervention Description
Outpatient behavioral counseling
Intervention Type
Behavioral
Intervention Name(s)
Low fat diet
Intervention Description
Outpatient behavioral counseling
Primary Outcome Measure Information:
Title
percent liver fat as determined by nMR spectroscopy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
hepatic steatosis as measured by T1 weighted MRI images
Time Frame
6 monhts
Title
visceral fat
Time Frame
6 months
Title
liver function tests
Time Frame
6 months
Title
measures of oxidative stress
Time Frame
6 months
Title
measures of chronic inflammation
Time Frame
6 months
Title
insulin resistance
Time Frame
6 months
Title
serum lipids
Time Frame
6 months
Title
blood pressure
Time Frame
6 months
Title
insulin secretion
Time Frame
baseline
Title
measures of glucose tolerance
Time Frame
6 months
Title
adiponectin
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Ludwig, MD, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17890486
Citation
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. doi: 10.1038/oby.2007.260.
Results Reference
background
PubMed Identifier
23705885
Citation
Ramon-Krauel M, Salsberg SL, Ebbeling CB, Voss SD, Mulkern RV, Apura MM, Cooke EA, Sarao K, Jonas MM, Ludwig DS. A low-glycemic-load versus low-fat diet in the treatment of fatty liver in obese children. Child Obes. 2013 Jun;9(3):252-60. doi: 10.1089/chi.2013.0022. Epub 2013 May 24.
Results Reference
derived
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Effects of a Low Glycemic Load Diet on Fatty Liver in Children
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