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

NCT01100398 | Completed DMC

• 1 other identifier: Williams-NASH1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver

Keywords

Fatty liver disease

Study Arms (1)

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

Interventions

possible liver biopsy and serum collection PROCEDURE

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.

NAFLD/NASH prevalence

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• ETOH consumption over 20 grams/day
• known fatty liver disease, chronic liver disease, HIV, or medication ingestion associated with fatty liver disease

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• Williams CD, Stengel J, Asike MI, Torres DM, Shaw J, Contreras M, Landt CL, Harrison SA. Prevalence of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis among a largely middle-aged population utilizing ultrasound and liver biopsy: a prospective study. Gastroenterology. 2011 Jan;140(1):124-31. doi: 10.1053/j.gastro.2010.09.038. Epub 2010 Sep 19.

  PMID: 20858492 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

liver biopsies and serum blood samples may be obtained

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Stephen Harrison, MD

  Brooke Army Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 9, 2010
• Study Start: January 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 24, 2010

Record last verified: 2010-12

Locations

US (1)