NAFLD Among Patients With Chronic Kidney Disease and the Effect of Kidney Transplantation

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 scheduled for kidney transplantation and the possible effect of kidney transplantation on NAFLD.

The project is a prospective cohort study. The effect of kidney transplantation in patients with prediabetes or normal glucose tolerance compared to healthy controls will be examined regarding development and progression of fat accumulation in the liver.

Fat accumulation in the liver will be determined by magnetic resonance (MR) spectroscopy and the prevalence of NAFLD in the two groups 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.

An oral glucose tolerance test (OGTT) and an intra venous glucose infusion (IIGI) will be performed.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Chronic Kidney Diseases
• PreDiabetes
• Kidney Transplant

Interventions

DIAGNOSTIC_TEST

MR spectroscopy of the liver

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

DIAGNOSTIC_TEST

Fibroscan of the liver

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.

DIAGNOSTIC_TEST

Oral glucose tolerance test (OGTT)

OGTT with incretin hormones. Measured for three hours.

DIAGNOSTIC_TEST

Intra venous glucose infusion (IIGI)

This test is combined with the OGTT to compare responses of parenteral vs enteral stimulation. The test is followed by a bolus of 5 g of L-arginin.

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

• Steno Diabetes Center Copenhagen

  collaborator OTHER

• Herlev and Gentofte Hospital

  collaborator OTHER

• The Novo Nordisk Foundation Center for Basic Metabolic Research

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Bo Feldt-Rasmussen, Professor · Rigshospitalet, Denmark

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-29

Primary Completion

2021-02-25

Completion

2022-03-31

FDA Device

Yes

Countries

• Denmark

Study Locations