An Observational Study in Patients with T2DM
Status: Currently recruiting subjects
Required visits: Single visit
Age of participants: Greater than 50 years
Gender of participants: Male and Female
PI: Rohit Loomba, MD
This is a prospective cohort study consisting of a one-time visit by diabetic pateients with optional following liver biopsy. The aim of the study is to conduct an epidemiological study of liver disorders in patients wiht T2DM.
During the visit, the diabetic 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 ultrasound transient
elastography. 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, peripheral blood mononuclear cells (PBMCs), whole blood, urine,
and stool will be stored for future studies. Results from history, physical
exam, and MRI and ultrasound 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.
Results from history, physical exam, and radiographic imaging will be used together with previously available genetic data to study genetic covariance of nonalcoholic fatty liver disease (NAFLD) and traits of the metabolic syndrome.
For additional questions regarding this study, please contact:
Shirin Bassirian, MD
Clinical Research Coordinator