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

Completed

• Conditions: Nonalcoholic Steatohepatitis

• Registration Number: NCT04462081
• Lead Sponsor: University of California, San Diego

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-12-17
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-09
• Study First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Liver Fat as Measured by MRI-PDFF	Baseline	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

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States