NAFLD Among Patients With Type 2 Diabetes and CKD

NCT03826381 | Completed DMC

• 1 other identifier: NAFLD and CKD - Study 1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Prevalence of NAFLD and actual estimate of liver signal measured by MR spectroscopy

  Liver signal is measured by MR spectroscopy

  1 day

Secondary Outcomes (4)

• Prevalence and actual estimate of liver lipid signal measured by MR spectroscopy in relation to bile acids measured in the blood

  2 visits - MR spectroscopy one day, blood samples another day.

• NAFLD, as measured by MR spectroscopy, and its association with metabolomics and lipidomic profiles measured in the blood in relation to impaired renal function

  1 day

• The prevalence of fibrosis

  1 day

• NAFLD, as measured by MR spectroscopy, and its association with glucose profiles in relation to impaired renal function

  4 days

Study Arms (2)

Study 1: DM2 + normal kidney function

Number of patients: 54 Patients in this group are diagnosed with Diabetes type 2. Kidney function: eGFR is \> 60, absence of clinical proteinuria. Inclusion- and exclusion criteria are listed under section "Eligibility". Examinations performed in this group are listed under the section "Groups and Interventions" and the same as in the other group. The patients are examined once.

Diagnostic Test: Magnetic resonance (MR) spectroscopy of the liver; Diagnostic Test: Fibroscan; Device: Continuous glucose monitoring (CGM) for four days.; Radiation: Dual Energy X-ray Absorptiometry (DEXA) scan; Biological: Blood samples; Other: Clinical and demographic data

Study 1: DM2 + CKD stage 3-5

Number of patients: 54 Patients in this group are all diagnosed with diabetes type 2. Furthermore, the patients have chronic kidney disease stage 3-5 (eGFR \<60). Inclusion- and exclusion criteria are listed under section "Eligibility". Examinations performed in this group are listed under the section "Groups and Interventions" are the same as in the other group. The patients are examined once.

Diagnostic Test: Magnetic resonance (MR) spectroscopy of the liver; Diagnostic Test: Fibroscan; Device: Continuous glucose monitoring (CGM) for four days.; Radiation: Dual Energy X-ray Absorptiometry (DEXA) scan; Biological: Blood samples; Other: Clinical and demographic data

Interventions

Magnetic resonance (MR) spectroscopy of the liver DIAGNOSTIC_TEST

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

Study 1: DM2 + CKD stage 3-5; Study 1: DM2 + normal kidney function

Fibroscan DIAGNOSTIC_TEST

Transient Elastography for Measurement of liver fibrosis.

Study 1: DM2 + CKD stage 3-5; Study 1: DM2 + normal kidney function

Continuous glucose monitoring (CGM) for four days. DEVICE

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

Study 1: DM2 + CKD stage 3-5; Study 1: DM2 + normal kidney function

Dual Energy X-ray Absorptiometry (DEXA) scan RADIATION

DEXA-scan of the body composition.

Study 1: DM2 + CKD stage 3-5; Study 1: DM2 + normal kidney function

Blood samples BIOLOGICAL

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

Study 1: DM2 + CKD stage 3-5; Study 1: DM2 + normal kidney function

Clinical and demographic data OTHER

Measurements of blood pressure, pulse, height, weight.

Study 1: DM2 + CKD stage 3-5; Study 1: DM2 + normal kidney function

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total number of participants: 108 divided in two Groups: * 54 patients with diabetes type 2 and normal kidney function (eGFR \>60 and absense of clinical proteinuria) * 54 patients with diabetes type 2 and chronic kidney disease stage 3-5 The patients are recruited from the department of Endocrinology or Nephrology at Rigshospitalet (if necessary, from Herlev Hospital, Gentofte Hospital or Steno Diabetes Center Copenhagen also).

You may qualify if:

• Diagnosed type 2-diabetes
• eGFR \> 60 ml/ min/ 1,73 m2 with absence of proteinuria (N=54) OR eGFR \< 60 ml/ min/ 1,73 m2 (N=54)
• Outpatient at the department of endocrinology at either Rigshospitalet, Herlev Hospital, Gentofte Hospital or Steno Diabetes Center Copenhagen OR Outpatient at the department of nephrology at either Rigshospitalet or Herlev Hospital

You may not qualify if:

• End stage liver disease as diagnosed by MELD (model for end stage liver disease) criteria OR
• At the waiting list for liver transplantation OR
• Daily alcohol intake above 20 g and 30 g for women and men respectively OR
• Known hepatitis A, B or C or hepatocellular carcinoma or other known liver disease OR
• Dialysis therapy OR
• Pregnancy OR
• Weight \> 130 kg OR
• Implanted pacemaker

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Nephrology

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for both immediately analyses (basic lab data) and later analyses (bile acids,lipidomics and metabolomics) and stored for 10 years whereafter they will be destroyed.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Renal Insufficiency, Chronic

Interventions

Magnetic Resonance Imaging; Continuous Glucose Monitoring; Absorptiometry, Photon; Blood Specimen Collection; Demography

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Radiography; Densitometry; Photometry; Chemistry Techniques, Analytical; Specimen Handling; Punctures; Surgical Procedures, Operative; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Bo Feldt-Rasmussen, Professor

  Department of Nephrology, Rishospitalet, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: February 1, 2019
• Study Start: May 6, 2019
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)