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

Completed

• Conditions: Fatty Liver
• Interventions: Procedure: possible liver biopsy and serum collection

• Registration Number: NCT01100398
• Lead Sponsor: Brooke Army Medical Center

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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-23
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NAFLD/NASH prevalence	possible liver biopsy and serum collection	Any subject between the ages of 18-70 without known fatty liver disease who meet inclusion criteria

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States