Non-Alcoholic Fatty Liver DiseaseNCT03826381
NAFLD Among Patients With Type 2 Diabetes and CKD
An observational study of Non-Alcoholic Fatty Liver Disease and Chronic Kidney Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Chronic Kidney Diseases, Type2 Diabetes
- What is being tested?
- Magnetic resonance (MR) spectroscopy of the liver, Fibroscan and Continuous glucose monitoring (CGM) for four days.
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2019to 23 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
INTRODUCTION
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. The disease is defined by an increased fat accumulation in the liver cells (>5 %), not caused by excessive alcohol intake (a threshold of 20 g per day for women and 30 g per day for men), autoimmunity, drugs or viral hepatitis. The histological spectrum of NAFLD ranges from simple steatosis to non-alcoholic steatohepatitis (NASH). Simple steatosis defined as steatosis without injury of the hepatocytes in form of ballooning and NASH defined as the presence of hepatic steatosis and inflammation with ballooned hepatocytes with or without fibrosis. The degree of fibrosis is an important prognostic factor and is related to liver related complications and mortality.
Diabetes is the single most important cause of end-stage renal disease (ESRD). Furthermore, more than 25 % of patients with moderate to severe chronic kidney disease (CKD) have pre-diabetic characteristics such as impaired glucose tolerance or impaired fasting glucose. NAFLD represents an important pathogenic factor in the development of type 2-diabetes and is associated with an increased risk of cardiovascular disease, insulin resistance and overweight.
Previous studies of patients with CKD with/without diabetes demonstrated, with less sensitive ultrasonic methods than what we plan to use in the present project, a high prevalence of NAFLD. Furthermore, the presence of both NAFLD and CKD is likely to increase the risk for cardiovascular diseases and mortality, particular among overweight patients. NAFLD is present in both diabetic and nondiabetic patients with ESRD. The co-existence of CKD, NAFLD and gluco-metabolic disturbances, including diabetes, is a research topic with increasing focus on. Co-morbidities in CKD such as impaired insulin sensitivity, diabetes, impaired calcium-phosphate metabolism, hypertension and hypertriglyceridemia constitute risk factors for NAFLD. Unfortunately, several treatments of CKD, including kidney transplantation, have been shown to impair lipid metabolism and increase insulin resistance especially in the liver. Importantly, lifestyle changes and medical treatment modalities have been shown to have only minor impact on reducing the prevalence of these disturbances in patients with CKD.
In patients with NAFLD, either due to metabolic stress (obesity) or toxic substances (immunosuppressive treatment), liver damage and the impact on insulin resistance is reflected in characteristic modifications of metabolites and lipids in liver tissue, as well as in circulating blood, which may help to identify and interpret the pathogenesis of liver damage in the setting of CKD. One recent hypothesis for linking liver damage and CKD involves a change in gut microbiota due to impaired renal function, leading to a leaky gut with damage of the gut-blood barrier. This transfers gut microbiota metabolites to the blood, leading to a pathogen-associated molecular pattern, reflected in changes in lipidomic and metabolomic profile in the blood. Such changes have in other conditions been associated with insulin resistance and have been linked to liver damage leading to NAFLD and later potentially fibrosis.
Very little information about bile acid metabolism in the development of NAFLD in CKD patients with type 2-diabetes is available. Risk factors for NAFLD among patients with CKD have only been investigated in small-scale studies with often inadequate methods. No studies have investigated the impact of fat lipid content measured by MR spectroscopy in patients with type 2-diabetes and CKD stage 3-5. New therapeutic strategies for the diagnosis and management of NAFLD in patients with CKD with diabetes are needed and important challenges in the elucidation of the ethology, pathogenesis and prevalence of NAFLD in CKD patients exist.Thus, this project will bring new knowledge among a group of patients with high morbidity and an increased risk of mortality - a knowledge that may provide new guidelines for prevention and treatment of NAFLD.
Objectives
The primary objective of this project is to study the association between the kidney function and the prevalence of NAFLD and the association with type 2-diabetes.
Furthermore, secondary objectives are to investigate potential associations between NAFLD in type 2-diabetes CKD patients and glucose profiles, metabolomics- and lipidomics profiles, intestinal peptides and the bile acid metabolism.
METHODS
Study design and population
This is a cross-sectional cohort study involving 54 patients with type 2-diabetes with normal kidney function and 54 patients with type 2-diabetes and CKD stage 3-5 (not on dialysis).
The patients will be recruited from the outdoor clinic of either endocrinology or nephrology at Rigshospitalet, Herlev Hospital, Steno Diabetes Center Copenhagen and Gentofte Hospital.
Examinations
The project involves following methods.
Magnetic resonance (MR) spectroscopy Fibroscan and clinical index Blood samples Dual Energy X-ray Absorptiometry scan Continuous Glucose Monitoring Clinical examination
Data and statistical analysis
The null hypothesis is that there is no difference in relative liver lipid signal measured by MR spectroscopy between type 2-diabetic patients with CKD stage 3-5 and patients with type 2-diabetes and normal renal function.
The alternative hypothesis is that there is a difference of 30% in liver lipid signal between type 2-diabetic patients with CKD stage 3-5 and patients with type 2-diabetes and normal renal function. In the literature content in relative liver fat signal in patients with type 2-diabetes and CKD 3-5 is about 60% and in type 2-diabetes patients with normal function it is about 30%. In a two-sided t-test with α=0.05 and power of 80%, a sample size of 98 patients in a parallel design is needed to demonstrate a difference in relative liver fat signal between type 2-diabetes patients with CKD 3 and 5 and type 2 diabetes patients with normal renal function of 30%. A total of 108 patients, including 10 extra patients, are planned to be examined.
After completion of the study and data completion the results are analysed according to primary and secondary endpoints. Results are reported as mean values with confidence interval or median and range. Data are analysed with parametric (normally distributed data) or non-parametric statistics (non-normal distributed data). A 95 % confidence interval is accepted as statistically significant (p < 0.05).
All data will be pseudo anonymised.
- Being tested
- Magnetic resonance (MR) spectroscopy of the liver, Fibroscan, Continuous glucose monitoring (CGM) for four days., Dual Energy X-ray Absorptiometry (DEXA) scan, Blood samples
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance (MR) spectroscopy of the liverDiagnostic test
Magnetic resonance (MR) spectroscopy of the liver. Golden standard for non-invasive determination of NAFLD
FibroscanDiagnostic test
Transient Elastography for Measurement of liver fibrosis.
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.
Dual Energy X-ray Absorptiometry (DEXA) scanRadiation
DEXA-scan of the body composition.
Blood samplesBiological
Immediately analyse of basic lab data. Later analyses for glucagon, amino acids, bile acids, lipidomics and metabolomics.
Clinical and demographic dataOther
Measurements of blood pressure, pulse, height, weight.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of NAFLD and actual estimate of liver signal measured by MR spectroscopy
Liver signal is measured by MR spectroscopy
Measured: 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
Liver lipid signal measured by MR spectroscopy. Bile acids are measured and analysed from blood samples.
Measured: 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
Measured by blood samples.
Measured: 1 day
The prevalence of fibrosis
As determined by fibroscan of the liver.
Measured: 1 day
NAFLD, as measured by MR spectroscopy, and its association with glucose profiles in relation to impaired renal function
Continuous Glucose Monitoring is used.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start6 May 2019
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo Feldt-Rasmussen, Professor, Principal investigator, Department of Nephrology, Rishospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826381
- Sponsor's protocol ID
- NAFLD and CKD - Study 1
- Status last verified
- Aug 2021
- First submitted
- 18 Mar 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03826381
- Acronym / sponsor ID
- NAFLD and CKD - Study 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION
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. The disease is defined by an increased fat accumulation in the liver cells (>5 %), not caused by excessive alcohol intake (a threshold of 20 g per day for women and 30 g per day for men), autoimmunity, drugs or viral hepatitis. The histological spectrum of NAFLD ranges from simple steatosis to non-alcoholic steatohepatitis (NASH). Simple steatosis defined as steatosis without injury of the hepatocytes in form of ballooning and NASH defined as the presence of hepatic steatosis and inflammation with ballooned hepatocytes with or without fibrosis. The degree of fibrosis is an important prognostic factor and is related to liver related complications and mortality.
Diabetes is the single most important cause of end-stage renal disease (ESRD). Furthermore, more than 25 % of patients with moderate to severe chronic kidney disease (CKD) have pre-diabetic characteristics such as impaired glucose tolerance or impaired fasting glucose. NAFLD represents an important pathogenic factor in the development of type 2-diabetes and is associated with an increased risk of cardiovascular disease, insulin resistance and overweight.
Previous studies of patients with CKD with/without diabetes demonstrated, with less sensitive ultrasonic methods than what we plan to use in the present project, a high prevalence of NAFLD. Furthermore, the presence of both NAFLD and CKD is likely to increase the risk for cardiovascular diseases and mortality, particular among overweight patients. NAFLD is present in both diabetic and nondiabetic patients with ESRD. The co-existence of CKD, NAFLD and gluco-metabolic disturbances, including diabetes, is a research topic with increasing focus on. Co-morbidities in CKD such as impaired insulin sensitivity, diabetes, impaired calcium-phosphate metabolism, hypertension and hypertriglyceridemia constitute risk factors for NAFLD. Unfortunately, several treatments of CKD, including kidney transplantation, have been shown to impair lipid metabolism and increase insulin resistance especially in the liver. Importantly, lifestyle changes and medical treatment modalities have been shown to have only minor impact on reducing the prevalence of these disturbances in patients with CKD.
In patients with NAFLD, either due to metabolic stress (obesity) or toxic substances (immunosuppressive treatment), liver damage and the impact on insulin resistance is reflected in characteristic modifications of metabolites and lipids in liver tissue, as well as in circulating blood, which may help to identify and interpret the pathogenesis of liver damage in the setting of CKD. One recent hypothesis for linking liver damage and CKD involves a change in gut microbiota due to impaired renal function, leading to a leaky gut with damage of the gut-blood barrier. This transfers gut microbiota metabolites to the blood, leading to a pathogen-associated molecular pattern, reflected in changes in lipidomic and metabolomic profile in the blood. Such changes have in other conditions been associated with insulin resistance and have been linked to liver damage leading to NAFLD and later potentially fibrosis.
Very little information about bile acid metabolism in the development of NAFLD in CKD patients with type 2-diabetes is available. Risk factors for NAFLD among patients with CKD have only been investigated in small-scale studies with often inadequate methods. No studies have investigated the impact of fat lipid content measured by MR spectroscopy in patients with type 2-diabetes and CKD stage 3-5. New therapeutic strategies for the diagnosis and management of NAFLD in patients with CKD with diabetes are needed and important challenges in the elucidation of the ethology, pathogenesis and prevalence of NAFLD in CKD patients exist.Thus, this project will bring new knowledge among a group of patients with high morbidity and an increased risk of mortality - a knowledge that may provide new guidelines for prevention and treatment of NAFLD.
Objectives
The primary objective of this project is to study the association between the kidney function and the prevalence of NAFLD and the association with type 2-diabetes.
Furthermore, secondary objectives are to investigate potential associations between NAFLD in type 2-diabetes CKD patients and glucose profiles, metabolomics- and lipidomics profiles, intestinal peptides and the bile acid metabolism.
METHODS
Study design and population
This is a cross-sectional cohort study involving 54 patients with type 2-diabetes with normal kidney function and 54 patients with type 2-diabetes and CKD stage 3-5 (not on dialysis).
The patients will be recruited from the outdoor clinic of either endocrinology or nephrology at Rigshospitalet, Herlev Hospital, Steno Diabetes Center Copenhagen and Gentofte Hospital.
Examinations
The project involves following methods.
Magnetic resonance (MR) spectroscopy Fibroscan and clinical index Blood samples Dual Energy X-ray Absorptiometry scan Continuous Glucose Monitoring Clinical examination
Data and statistical analysis
The null hypothesis is that there is no difference in relative liver lipid signal measured by MR spectroscopy between type 2-diabetic patients with CKD stage 3-5 and patients with type 2-diabetes and normal renal function.
The alternative hypothesis is that there is a difference of 30% in liver lipid signal between type 2-diabetic patients with CKD stage 3-5 and patients with type 2-diabetes and normal renal function. In the literature content in relative liver fat signal in patients with type 2-diabetes and CKD 3-5 is about 60% and in type 2-diabetes patients with normal function it is about 30%. In a two-sided t-test with α=0.05 and power of 80%, a sample size of 98 patients in a parallel design is needed to demonstrate a difference in relative liver fat signal between type 2-diabetes patients with CKD 3 and 5 and type 2 diabetes patients with normal renal function of 30%. A total of 108 patients, including 10 extra patients, are planned to be examined.
After completion of the study and data completion the results are analysed according to primary and secondary endpoints. Results are reported as mean values with confidence interval or median and range. Data are analysed with parametric (normally distributed data) or non-parametric statistics (non-normal distributed data). A 95 % confidence interval is accepted as statistically significant (p < 0.05).
All data will be pseudo anonymised.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1: DM2 + normal kidney function | – | 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 dataNumber 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. |
| Study 1: DM2 + CKD stage 3-5 | – | 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 dataNumber 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance (MR) spectroscopy of the liverMagnetic resonance (MR) spectroscopy of the liver. Golden standard for non-invasive determination of NAFLD | Diagnostic test | Study 1: DM2 + CKD stage 3-5, Study 1: DM2 + normal kidney function |
| FibroscanTransient Elastography for Measurement of liver fibrosis. | Diagnostic test | Study 1: DM2 + CKD stage 3-5, Study 1: DM2 + normal kidney function |
| 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. | Device | Study 1: DM2 + CKD stage 3-5, Study 1: DM2 + normal kidney function |
| Dual Energy X-ray Absorptiometry (DEXA) scanDEXA-scan of the body composition. | Radiation | Study 1: DM2 + CKD stage 3-5, Study 1: DM2 + normal kidney function |
| Blood samplesImmediately analyse of basic lab data. Later analyses for glucagon, amino acids, bile acids, lipidomics and metabolomics. | Biological | Study 1: DM2 + CKD stage 3-5, Study 1: DM2 + normal kidney function |
| Clinical and demographic dataMeasurements of blood pressure, pulse, height, weight. | Other | Study 1: DM2 + CKD stage 3-5, Study 1: DM2 + normal kidney function |
Primary outcome
Prevalence of NAFLD and actual estimate of liver signal measured by MR spectroscopy
Time frame: 1 day
Liver signal is measured by MR spectroscopy
4 secondary outcomes
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.
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
The prevalence of fibrosis
Time frame: 1 day
NAFLD, as measured by MR spectroscopy, and its association with glucose profiles in relation to impaired renal function
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Feldt-Rasmussen, Professor principal investigator
Department of Nephrology, Rishospitalet, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Chronic Kidney Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NAFLD and actual estimate of liver signal measured by MR spectroscopy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.