Status:
COMPLETED
Effect of Diet Composition on Liver Fat and Glucose Metabolism
Lead Sponsor:
University of Washington
Collaborating Sponsors:
VA Puget Sound Health Care System
Conditions:
Fatty Liver
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study is designed to determine if the amount of fat and saturated fat in the diet contributes to the development of a condition called fatty liver disease in the absence of changes in weight.
Detailed Description
A condition called non-alcoholic steatohepatitis is characterized by fat accumulation in the liver and associated inflammation. This condition is strongly associated with obesity, insulin resistance a...
Eligibility Criteria
Inclusion
- Age 18-55 years old, men and women, otherwise in good general health, BMI \>27 kg/m2
Exclusion
- Abnormal glucose tolerance, fasting glucose\>100 mg/dl or diabetes
- History of liver condition or alanine aminotransferase (ALT) above the upper limit of the normal range
- Use of medications that cause insulin resistance or fatty liver: niacin, glucocorticoids, estrogens, tamoxifen, amiodarone, accutane, sertraline, atypical antipsychotics, anti-HIV medications
- Chronic use of anti-inflammatory medications (aspirin, ibuprofen, naprosyn, steroids, etc)
- Average alcohol intake \>20 grams/day
- Tobacco use
- Creatinine \>1.5 mg/dl for men and \>1.4 mg/dl for women
- Hematocrit \<33%
- Pregnancy or lactation
- Significant weight loss within the past 6 months (\>5% body weight)
- Claustrophobia or any contraindications to being placed in the magnet for the MRS scan such as pacemakers, defibrillators, brain aneurysm clips, etc.
- Other serious medical conditions or inflammatory conditions such as cancer, inflammatory arthritis, etc.
- History of multiple food allergies or intolerances or severe food allergies
- History of coronary artery disease, history of or treatment of hyperlipidemia, LDL \>200 mg/dl, fasting triglycerides \>300 mg/dl
- Weight \>300 pounds
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00930371
Start Date
June 1 2009
End Date
September 1 2012
Last Update
December 3 2015
Active Locations (2)
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1
University of Washington
Seattle, Washington, United States, 98108
2
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108