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

This study has been completed.
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01100398
First received: April 8, 2010
Last updated: December 23, 2010
Last verified: December 2010
  Purpose

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 Intervention
Fatty Liver
Procedure: possible liver biopsy and serum collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Biospecimen Retention:   Samples Without DNA

liver biopsies and serum blood samples may be obtained


Enrollment: 400
Study Start Date: January 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Brooke Army Medical Center

Additional 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
Study First Received: April 8, 2010
Last Updated: December 23, 2010
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Fatty liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014