Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Primary Purpose
Fatty Liver, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat diet
Traditional diet
Sponsored by
About this trial
This is an interventional treatment trial for Fatty Liver focused on measuring steatosis, fatty liver, insulin sensitivity, fatty liver (steatosis)
Eligibility Criteria
Inclusion Criteria:
- 10 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)
Exclusion Criteria:
- 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%)
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-fat diet
Traditional
Arm Description
20% kcals from fat diet followed for 8 weeks then 8 weeks of maintenance diet with visits to dietitian every other week
Traditional low-fat diet given and dietitian follows up in 16 weeks
Outcomes
Primary Outcome Measures
Liver Enzyme, liver and muscle fat content, glucose tolerance status
Secondary Outcome Measures
plasma lipid levels
Full Information
NCT ID
NCT00585299
First Posted
December 22, 2007
Last Updated
June 16, 2014
Sponsor
Yale University
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00585299
Brief Title
Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Official Title
Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study will have two groups: one group that eats a moderate calorie, low-fat diet and is weighed regularly (every other week for 16 weeks) and the other who receives traditional diet therapy and returns in 16 weeks. Both groups will undergo procedures that test glucose tolerance and measure liver and muscle fat content before and after study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Insulin Resistance
Keywords
steatosis, fatty liver, insulin sensitivity, fatty liver (steatosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-fat diet
Arm Type
Experimental
Arm Description
20% kcals from fat diet followed for 8 weeks then 8 weeks of maintenance diet with visits to dietitian every other week
Arm Title
Traditional
Arm Type
Active Comparator
Arm Description
Traditional low-fat diet given and dietitian follows up in 16 weeks
Intervention Type
Other
Intervention Name(s)
Low-fat diet
Intervention Description
20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks
Intervention Type
Other
Intervention Name(s)
Traditional diet
Intervention Description
Traditional low-fat diet with dietitian follow-up in 16 weeks
Primary Outcome Measure Information:
Title
Liver Enzyme, liver and muscle fat content, glucose tolerance status
Time Frame
16-18 weeks
Secondary Outcome Measure Information:
Title
plasma lipid levels
Time Frame
16-18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
10 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)
Exclusion Criteria:
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Caprio, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
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