NCT00480922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

2.6 years

First QC Date

May 23, 2007

Last Update Submit

August 25, 2011

Conditions

Hepatic Steatosis

Keywords

non-alcoholic fatty liver diseasesteatohepatitisoverweightinsulin resistance

Outcome Measures

Primary Outcomes (1)

  • percent liver fat as determined by nMR spectroscopy

    6 months

Secondary Outcomes (11)

  • hepatic steatosis as measured by T1 weighted MRI images

    6 monhts

  • visceral fat

    6 months

  • liver function tests

    6 months

  • measures of oxidative stress

    6 months

  • measures of chronic inflammation

    6 months

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

A low glycemic load diet

Behavioral: Low glycemic load diet

2

ACTIVE COMPARATOR

Low fat diet

Behavioral: Low fat diet

Interventions

Low glycemic load dietBEHAVIORAL

Outpatient behavioral counseling

1
Low fat dietBEHAVIORAL

Outpatient behavioral counseling

2

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 17890486BACKGROUND

  • 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.

    PMID: 23705885DERIVED

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver DiseaseOverweightInsulin Resistance

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • David S Ludwig, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 31, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

US(1)