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

Completed

Conditions studied: Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT04462081

Run by

University of California, San Diego

People needed

100

Starts

2013-01-01

Expected to finish

2015-01-01

Last updated by the study team

2020-07-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Drug-induced liver disease as defined on the basis of typical exposure and history.
• Bile duct obstruction as shown by imaging studies.
• History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, methotrexate, amiodarone or tetracycline in the previous 6 months.
• Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
• Absence of regular and/or excessive use of alcohol(defined as >30g/day for males and >15g/day for females) for a period longer than 2 years at any times in the last 10 years
• Serum creatinine> 1.5 mg/dL
• The subject is a pregnant or nursing female
• Contraindications to computed tomography (CT) or magnetic resonance imaging (MRI):
• The subject has any contraindication to MR imaging, such as patients with cardiac pacemaker or defibrillator, neurostimulator, intravascular stents, coils, valves, surgical clips, implanted electronic infusion pump, ferromagnetic foreign body or other conditions that would preclude proximity to a strong magnetic field.
• The subject has a history of extreme claustrophobia.
• The subject cannot fit inside the MRI or CT machine

Where it is running

• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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