NAFLD Among Patients With Type 2 Diabetes and CKD

Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries affecting approximately 30 % of the general adult population. It represents an important pathogenic factor in the development of type 2-diabetes and is associated with a high risk of cardiovascular disease. Previous studies of patients with chronic kidney disease (CKD) have demonstrated an increased risk for NAFLD and the presence of both CKD and NAFLD is likely to increase the risk for cardiovascular disease.

The present protocol describes a study of the prevalence and etiology of NAFLD among patients with type 2-diabetes with CKD.

The study is a cross-sectional study. Fat accumulation in the liver will be determined by Magnetic resonance (MR) spectroscopy and the prevalence of NAFLD among patients with type 2-diabetes with normal kidney function or CKD stage 3-5 will be investigated. A continuous glucose monitoring (CGM) for four days, Dual Energy X-ray Absorptiometry (DEXA) scanning, fibro scanning of the liver, bile acid analysis, metabolomic and lipidomic analysis will also be performed.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Chronic Kidney Diseases
• Type2 Diabetes

Interventions

DIAGNOSTIC_TEST

Magnetic resonance (MR) spectroscopy of the liver

Magnetic resonance (MR) spectroscopy of the liver. Golden standard for non-invasive determination of NAFLD

DIAGNOSTIC_TEST

Fibroscan

Transient Elastography for Measurement of liver fibrosis.

DEVICE

Continuous glucose monitoring (CGM) for four days.

CGM is attached to the abdominal skin for four days. Afterwards data is converted and analysed in a computer program.

RADIATION

Dual Energy X-ray Absorptiometry (DEXA) scan

DEXA-scan of the body composition.

BIOLOGICAL

Blood samples

Immediately analyse of basic lab data. Later analyses for glucagon, amino acids, bile acids, lipidomics and metabolomics.

OTHER

Clinical and demographic data

Measurements of blood pressure, pulse, height, weight.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Bo Feldt-Rasmussen, Professor · Department of Nephrology, Rishospitalet, University of Copenhagen

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-06

Primary Completion

2021-06-23

Completion

2021-06-23

Countries

• Denmark

Study Locations