NCT00585299

Brief Summary

To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

3.7 years

First QC Date

December 22, 2007

Last Update Submit

June 16, 2014

Conditions

Fatty LiverInsulin Resistance

Keywords

steatosisfatty liverinsulin sensitivityfatty liver (steatosis)

Outcome Measures

Primary Outcomes (1)

  • Liver Enzyme, liver and muscle fat content, glucose tolerance status

    16-18 weeks

Secondary Outcomes (1)

  • plasma lipid levels

    16-18 weeks

Study Arms (2)

Low-fat diet

EXPERIMENTAL

20% kcals from fat diet followed for 8 weeks then 8 weeks of maintenance diet with visits to dietitian every other week

Other: Low-fat dietOther: Traditional diet

Traditional

ACTIVE COMPARATOR

Traditional low-fat diet given and dietitian follows up in 16 weeks

Other: Traditional diet

Interventions

Low-fat dietOTHER

20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks

Low-fat diet
Traditional dietOTHER

Traditional low-fat diet with dietitian follow-up in 16 weeks

Low-fat dietTraditional

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 21 yrs of age
  • Non-smoking
  • BMI \>95th percentile for age and gender, but BMI \<40
  • Suspicion of fatty liver, with a high ALT (\>35)
  • Normal glucose tolerance or prediabetes (impaired glucose tolerance or impaired fasting glucose)

You may not qualify if:

  • Females of child-bearing potential who are not using birth control
  • Pregnant or lactating females
  • Current medications except oral anti-diabetic medications and hormonal birth control
  • Lipid-lowering medication that increases liver enzymes
  • Significant kidney dysfunction (creatinine \>1.5 mg/dL)
  • Current heavy ethanol use or recent history of binge drinking
  • History or evidence of hepatitis A, B, or C, Wilson's Disease, or alpha-1-antitrypsin deficiency
  • Known to be HIV positive
  • Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA classification as Functional Class III or IV
  • Major vascular event within 6 months of screening (e.g. MI, stroke)
  • Active cancer within 5 years prior to screening
  • Current systemic disease, including type 1 or 2 diabetes
  • Enrolled in another research study within 1 month prior to screening
  • Implanted paramagnetic material (all subjects will need to fill out the Yale Magnetic Resonance Center safety checklist)
  • Anemia (HCT \<35%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Fatty LiverInsulin Resistance

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Sonia Caprio, MD

    Yale University

    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

December 22, 2007

First Posted

January 3, 2008

Study Start

October 1, 2006

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

US(1)