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Non Alcoholic Fatty Liver Disease and Coronary Heart Disease in Type 2 Diabetes Patients | Clinical Trials | Clareo Health

COMPLETED

Non Alcoholic Fatty Liver Disease and Coronary Heart Disease in Type 2 Diabetes Patients

NCT04462081•University of California, San Diego

View on ClinicalTrials.gov

Summary

To assess the feasibility in diabetics in a primary care setting of screening for NAFLD and advanced fibrosis, by using non-invasive magnetic resonance imaging (MRI) to estimate the hepatic proton density fat fraction (MRI-PDFF) and magnetic resonance elastography (MRE) to estimate hepatic stiffness.

Detailed Description

This is a prospective cohort study consisting of a one-time visit by diabetic patients with optional following liver biopsy. The aim of the study is to evaluate whether liver fat fraction and liver stiffness, as determined by magnetic resonance imaging, are associated with subclinical cardiovascular disease, as evaluated by coronary artery calcium scan in diabetics. During the visit, patients will undergo review of medical history, vitals (including body mass index, blood pressure), physical exam, blood work, urine collection, ECG, magnetic resonance imaging (MRI), including MR proton density fat fraction (MRI-PDFF) and MR elastography, ultrasound using acoustic radiation force impulse (ARFI) imaging, and computed tomography (CT) scan for coronary artery calcium scoring. Blood work will be sent for labs relevant to traits of metabolic syndrome including markers for diabetes (hemoglobin A1C, fasting glucose) and hyperlipidemia (lipid panel). Serum, plasma and whole blood will be stored for future studies. Results from history, physical exam, and radiographic imaging will be analyzed and if they indicate the presence of nonalcoholic steatohepatitis, patients will be offered an optional liver biopsy for further assessment. All patients will be invited to continue in the study and have follow-up visits every two years for a total duration of the study of 5 years.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults, age 21 or above, with diagnosis of T2DM according to the American Diabetes Association (ADA) clinical practice recommendations.
•T2DM is defined according to American Diabetes Association (ADA) clinical practice recommendations if one of the following criteria is met:
•* Diabetes symptoms (polyuria, polydipsia, polyphagia, increased fatigue, weight loss, blurred vision) exist and casual plasma glucose ≥200 mg/dl (11.1 mmol/l) OR
•* Fasting plasma glucose (FPG) ≥126 mg/dl (7.0 mmol/l); OR
•* Plasma glucose ≥200 mg/dl (11.1 mmol/l) during a 75-g oral glucose tolerance test (OGTT) (25).
•If any of these test results occur, testing should be repeated on a different day to confirm the diagnosis. OR
•* hemoglobin A1C (HbA1C) ≥6.5% (26).
•The subject is fully informed and willing and able to perform all the procedures specified in the protocol and signed a written informed consent to participate

Exclusion Criteria

•Documented history of cardiovascular disease (CVD), such as acute coronary syndrome (ST elevation myocardial infarction, non-ST elevation myocardial infarction, unstable angina), stable angina, history of angioplasty or stent placement, cerebrovascular disease (ischemic or hemorrhagic stroke), and peripheral vascular disease.
•History of congestive heart failure
•Evidence of other causes of chronic liver disease
•* Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
•* Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab).
•* Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
•* Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
•* Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
•* Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
•* Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
+11 more criteria

Locations (1)

University of California, San Diego

San Diego, California, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

July 8, 2020

Enrollment

100

ACTUAL participants

Conditions

Nonalcoholic Steatohepatitis

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

NCT02815891

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

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RECRUITINGNA

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

NCT03587831

NASH - Nonalcoholic Steatohepatitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Non Alcoholic Fatty Liver Disease and Coronary Heart Disease in Type 2 Diabetes Patients

Inclusion Criteria

Exclusion Criteria

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects

Hepatic Energy Fluxes in NASH and NAS Patients

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

LITMUS Imaging Study