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Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) Utilizing Ultrasound and Percutaneous Liver Biopsy

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ClinicalTrials.gov Identifier: NCT01100398
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : December 24, 2010
Sponsor:
Information provided by:
Brooke Army Medical Center

Study Description
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Brief Summary:
Prospective determination of the prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)in a primary care setting using ultrasound and percutaneous liver biopsy.

Condition or disease Intervention/treatment
Fatty Liver Procedure: possible liver biopsy and serum collection

Detailed Description:
Patients between the ages of 18 and 70 years who are eligible for care at Brooke Army Medical Center are considered for enrollment. After obtaining informed consent, a baseline questionnaire is given to patients who present to the Primary Care Clinic for routine clinic visits or during colon cancer screening classes within the Gastroenterology Clinic. The questionnaire includes information about the patient's past medical history to include: known history of chronic liver disease, current medications, current and past alcohol ingestion, dietary habits that included consumption of fructose containing beverages and frequency of fast food visits. Patients are excluded if they are found to have a history of chronic liver disease, HIV, on medications that are associated with a fatty liver, or consumption of more than 20 grams of alcohol per day. Right upper quadrant ultrasound will then be performed to determine if there is evidence of fatty liver disease. All patients with a positive ultrasound for hepatic steatosis are then offered a liver biopsy after obtaining fasting blood work that included a complete blood count, coagulation studies, liver function tests, fasting lipid panel, glucose and insulin. Patients with a negative ultrasound for fatty liver are not referred for liver biopsy and are considered as completed study patients. Serum is also stored for adipokine and cytokine analysis. A study investigator using a 14g Bard Monopty biopsy gun will perform the liver biopsy. A single expert hepatopathologist will review all liver biopsies and utilize the Brunt system (9) for grading and staging of steatohepatitis if present.

Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis Utilizing Ultrasound and Percutaneous Liver Biopsy: A Prospective Cohort Study
Study Start Date : January 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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Groups and Cohorts
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Group/Cohort Intervention/treatment
NAFLD/NASH prevalence
Any subject between the ages of 18-70 without known fatty liver disease who meet inclusion criteria
 Procedure: possible liver biopsy and serum collection
All patients with a positive ultrasound for hepatic steatosis offered a liver biopsy after obtaining fasting blood work that included a complete blood count, coagulation studies, liver function tests, fasting lipid panel, glucose and insulin. Patients with a negative ultrasound for fatty liver are not referred for liver biopsy and are considered as completed study patients. Serum is also stored for adipokine and cytokine analysis. A study investigator using a 14g Bard Monopty biopsy gun performs the liver biopsy.


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
liver biopsies and serum blood samples may be obtained

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 to 70 years of age who have access to care through the Primary Care Clinics or the Gastroenterology Clinic at Brooke Army Medical Center
Criteria

Inclusion Criteria:

  • Patients 18 to 70 years of age were recruited from the Primary Care Clinics or the Gastroenterology Clinic at Brooke Army Medical Center. After completing a baseline questionnaire, all patients had a right upper quadrant ultrasound. If fatty liver was identified, then laboratory data and a liver biopsy were obtained.

Exclusion Criteria:

  • ETOH consumption over 20 grams/day
  • known fatty liver disease, chronic liver disease, HIV, or medication ingestion associated with fatty liver disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100398


Locations
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Study Director: Stephen Harrison, MD Brooke Army Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christopher D. Williams, MD (fellow, gastroenterology), Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01100398     History of Changes
Other Study ID Numbers: Williams-NASH1
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: December 24, 2010
Last Verified: December 2010

Keywords provided by Brooke Army Medical Center:
Fatty liver disease

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
 Digestive System Diseases
Liver Extracts
Hematinics