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NAFLD Among Patients With Type 2 Diabetes and CKD

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ClinicalTrials.gov Identifier: NCT03826381
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Bo Feldt-Rasmussen, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease Chronic Kidney Diseases Type2 Diabetes 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

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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence and Metabolic Impact of Non-alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes With Normal Renal Function or Chronic Kidney Disease
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021


Group/Cohort Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Prevalence of NAFLD and actual estimate of liver signal measured by MR spectroscopy [ Time Frame: 1 day ]
    Liver signal is measured by MR spectroscopy


Secondary Outcome Measures :
  1. Prevalence and actual estimate of liver lipid signal measured by MR spectroscopy in relation to bile acids measured in the blood [ Time Frame: 2 visits - MR spectroscopy one day, blood samples another day. ]
    Liver lipid signal measured by MR spectroscopy. Bile acids are measured and analysed from blood samples.

  2. NAFLD, as measured by MR spectroscopy, and its association with metabolomics and lipidomic profiles measured in the blood in relation to impaired renal function [ Time Frame: 1 day ]
    Measured by blood samples.

  3. The prevalence of fibrosis [ Time Frame: 1 day ]
    As determined by fibroscan of the liver.

  4. NAFLD, as measured by MR spectroscopy, and its association with glucose profiles in relation to impaired renal function [ Time Frame: 4 days ]
    Continuous Glucose Monitoring is used.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Criteria

INCLUSION CRITERIA:

  • 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

EXCLUSION CRITERIA

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826381


Contacts
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Contact: Therese Adrian, Dr 0045-3545 7187 kadr0005@regionh.dk
Contact: Mads Hornum, Dr. Ph.d. 0045-35451762 mads.hornum@regionh.dk

Locations
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Denmark
Department of Nephrology Recruiting
Copenhagen, Denmark, 2100
Contact: Therese Adrian, Dr    0045-3545 7187    kadr0005@regionh.dk   
Contact: Mads Hornum, Dr. Ph.d.    0045-3545 1762    mads.hornum@regionh.dk   
Principal Investigator: Bo Feldt-Rasmussen, Professor         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Bo Feldt-Rasmussen, Professor Department of Nephrology, Rishospitalet, University of Copenhagen
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Responsible Party: Bo Feldt-Rasmussen, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03826381    
Other Study ID Numbers: NAFLD and CKD - Study 1
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Digestive System Diseases