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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04462081
Non Alcoholic Fatty Liver Disease and Coronary Heart Disease in Type 2 Diabetes Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92103
- University of California, San Diego
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
- 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
Plan de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Liver Fat as Measured by MRI-PDFF
Periodo de tiempo: Baseline
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Evaluation of 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
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Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rohit Loomba, University of California, San Diego
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedades del HIGADO
- Enfermedades cardíacas
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- Hígado graso
- Enfermedad del hígado graso no alcohólico
Otros números de identificación del estudio
- NAFLD and CHD in Diabetes
Plan de datos de participantes individuales (IPD)
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