Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Adults (PREV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03142867
Recruitment Status : Unknown
Verified May 2017 by Angelo Paredes, The Geneva Foundation.
Recruitment status was:  Recruiting
First Posted : May 8, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Angelo Paredes, The Geneva Foundation

Brief Summary:
Nonalcoholic fatty liver disease (NAFLD) is a global health concern with a suspected increasing prevalence due to the rise in obesity and diabetes mellitus. The vast majority of patients will have isolated steatosis or steatosis with mild inflammation that is very unlikely to progress in severity. However, about 25% of patients with NAFLD have non-alcoholic steatohepatitis (NASH), the more aggressive form of the disease that is associated with fibrosis progression and potential risk for cirrhosis and end-stage liver disease complications. Additionally, multiple studies have demonstrated an association between NAFLD and the presence of coronary artery disease by either coronary CT angiography (CCTA) or coronary artery calcium (CAC) score. Cardiovascular disease is the most important cause of mortality in patients with the entire spectrum of NAFLD. In the era of advanced imaging and functional vascular assessment it is possible that novel risk assessments are poised to refine overall prognostic estimation in this population. Multiple analyses have suggested that NAFLD is an independent and strong predictor of significant CAD independent of cardiovascular risk factors, including a significant burden of high risk CCTA findings in one analysis of symptomatic patients in the emergency department. Given the multiple metabolic derangements inherent in the NAFLD population, endothelial dysfunction is also an important contributor to global cardiovascular dysfunction. Furthermore, data suggests that patients with NAFLD may be at increased risk of adenomatous polyp formation and colorectal adenocarcinoma. In addition, it is suboptimal to require a liver biopsy to diagnose NASH. Recent imaging advances have made it possible to assess liver fibrosis but have yet to be fully studied in NAFLD. The purpose of this study is to assess the current prevalence and severity of NAFLD in adult subjects. Secondary endpoints include correlation to new vascular function (cine scan of the abdominal aorta) and echocardiographic imaging modalities available at BAMC and to circulating biomarker panels as well as to determine the prevalence and severity of CAD by multidetector coronary CT angiography with subject outcomes being monitored prospectively. Additionally, correlation of NAFLD diagnosis to colonoscopy findings will be performed.

Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Other: non-applicable

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 950 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) in Adults
Actual Study Start Date : August 25, 2015
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 1, 2018


Group/Cohort Intervention/treatment
Control

The target population for this study is male and female patients (age 18 to 80) and will consist of retired and active military personnel and their dependents. There will be no race, ethnic, or gender limitations to enrollment.

The control group will be made of individuals who do not meet the qualifications for a liver biopsy.

Other: non-applicable
non-applicable

NAFLD

The target population for this study is male and female patients (age 18 to 80) and will consist of retired and active military personnel and their dependents. There will be no race, ethnic, or gender limitations to enrollment.

The NAFLD group will be made of individuals who qualify for a liver biopsy and have histologically proven NAFLD.

Other: non-applicable
non-applicable

NASH

The target population for this study is male and female patients (age 18 to 80) and will consist of retired and active military personnel and their dependents. There will be no race, ethnic, or gender limitations to enrollment.

The NASH group will be made of individuals who qualify for a liver biopsy and have histologically proven NASH.

Other: non-applicable
non-applicable




Primary Outcome Measures :
  1. Prevalence of NAFLD [ Time Frame: from the date of consent to the completion of phase I (up to 3 months) ]
    Determine the prevalence of NAFLD in military beneficiaries between ages 18 to 80. This will be determined by the % of subjects determined to have NAFLD via liver biopsy.

  2. Prevalence of NASH [ Time Frame: from the date of consent to the completion of phase I (up to 3 months) ]
    Determine the prevalence of NASH in military beneficiaries between ages 18 to 80. This will be determined by the % of subjects determined to have NASH via liver biopsy.


Secondary Outcome Measures :
  1. proton density fat fraction [ Time Frame: Determined at the date of MRI (1 day) ]
    % fat in the liver determined via MRI and LiverMultiScan software

  2. Liver stiffness measure by Fibroscan [ Time Frame: Determined at the date of Fibroscan (1 day) ]
    Liver stiffness will be determined via kPa value from Fibroscan

  3. Liver stiffness measure by MRE [ Time Frame: Determined at the date of MRE (1 day) ]
    Liver stiffness will be determined via kPa value from MRE

  4. Stages of fibrosis and grades of steatosis [ Time Frame: determined at the date of liver biopsy tissue evaluation (1 day) ]
    determined by a pathologist reading liver biopsy slides and Brunt scoring system

  5. Prevalence of colon polyps [ Time Frame: determined at the date of colonoscopy (1 day) ]
    Determine the prevalence and severity of colon polyps within the population of subjects identified as having NAFLD and correlate these findings to those without NAFLD.

  6. Prevalence and severity of CAD [ Time Frame: determined at the date of CCTA (1 day) ]
    Determine the prevalence and severity of CAD by CCTA and CAC scoring within the population of subjects identified as having NAFLD. Prospectively follow patients undergoing CCTA/CAC scoring for major cardiovascular events (myocardial infarction, stroke/TIA, coronary revascularization, or death).

  7. Prevalence and severity of endothelial dysfunction with peripheral tonometry [ Time Frame: determined at the date of the EndoPat Test (1 day) ]
    Determine the prevalence and severity of endothelial dysfunction with peripheral tonometry within the population of subjects identified as having NAFLD. Prospectively follow patients undergoing with peripheral tonometry for major cardiovascular events (myocardial infarction, stroke/TIA, coronary revascularization, or death).

  8. Prevalence of diastolic dysfunction [ Time Frame: determined at the date of the transthoracic echocardiogram (1 day) ]
    Determine the prevalence of diastolic dysfunction with transthoracic echocardiography within the population of subjects identified as having NAFLD


Biospecimen Retention:   Samples Without DNA
An additional 5 ml of whole blood and 5 ml of serum will be collected and stored by a research coordinator, nurse, research assistant, or investigator for analysis of specific biomarkers to include Hyaluronic acid, CK-18 (M30), FGF-21, Mac-2BP, FAS, AFP, YKL-40, Alpha-2-macroglobulin and a panel of 46 fatty acids during the liver biopsy appointment.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The patient population will include all adults presenting to the BAMC Gastroenterology clinic.

The target population for this study is male and female patients (age 18 to 80) and will consist of retired and active military personnel and their dependents. BAMC is the only study site. There will be no race, ethnic, or gender limitations to enrollment.

Criteria

Inclusion Criteria:

  • Phase I:

    1. Male and female patients (≥18 years of age to 80)
    2. Eligible for care at Brooke Army Medical Center

Phase II:

  1. Met the criteria for qualification for a percutaneous liver biopsy and completed Phase I
  2. Eligible for care at Brooke Army Medical Center

Exclusion Criteria:

  • Phase I:

    1. Patients with excessive alcohol use will be excluded as defined as >21 units of alcohol/week for men and 14 units of alcohol/week for women over a 2 year time frame. One drink "unit" or one standard drink is equivalent to a 12-ounce beer, a 4-ounce glass of wine, or a 1-ounce shot of hard liquor.
    2. Patients with prior history of liver disease to include chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, or prior documentation of NAFLD.
    3. Patients on medications known to cause fatty liver disease: tamoxifen, corticosteroids, amiodarone, methotrexate, valproic acid
    4. Patients carrying an implantable active medical device such as a pacemaker or a defibrillator
    5. Pregnant women

Phase II:

  1. CCTA/CAC only: GFR <60 mls/min/1.73m2 or IV contrast dye allergy
  2. CCTA/CAC only: contraindications to atrioventricular (AV) nodal blocking agents (high degree AV block without permanent pacemaker, asthma, allergy to nodal blocking agents).
  3. Known CAD defined as previous PCI or CABG (Note: Subjects with CCTA within the past 12 months will not be excluded from study and repeat scan will not be needed but the results of that previous scan will be included in the prevalence and severity analysis.)

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): NCT03142867


Contacts
Layout table for location contacts
Contact: Clinical Research Coordinator, MS jennifer.m.whitehead7.ctr@mail.mil

Locations
Layout table for location information
United States, Texas
San Antonio Military Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Jennifer M Whitehead, MS    210-916-9073    jennifer.m.whitehead7.ctr@mail.mil   
Sponsors and Collaborators
The Geneva Foundation
Investigators
Layout table for investigator information
Principal Investigator: Angelo H Paredes, MD Brooke Army Medical Center

Layout table for additonal information
Responsible Party: Angelo Paredes, Chief of Hepatology, The Geneva Foundation
ClinicalTrials.gov Identifier: NCT03142867     History of Changes
Other Study ID Numbers: 20513
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angelo Paredes, The Geneva Foundation:
Non-Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
Prevalence
Coronary Artery Disease
PDFF

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases