Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease

Study Overview
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Brief Summary
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The present study investigates relationship between non-alcoholic fatty liver disease and its risk factors, such as genetic background and diseases, such as chronic kidney disease and diabetes mellitus.

Detailed Description
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Non-alcoholic fatty liver disease (NAFLD) is a multisystemic disease, also affecting extrahepatic organs (1,2,6). According to former data, not only the prevalence of chronic hepatic disease, chronic cardiovascular diseases, but also the prevalence of chronic kidney disease (CKD) is higher in NAFLD (4,7). A strong association has been shown between diabetes mellitus (DM) and NAFLD as well (3,5,10). Many genetical factors have been studied in the background of NAFLD. Many studies have proved the effect of patatin-like phospholipase domain-containing protein 3 gene (PNPLA3) (8,9). Effect of numerous genetical polymorphisms has been suggested behind oxidative stress responsible for NAFLD (8).

Official Title
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Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease

Conditions
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Non-alcoholic Fatty Liver Disease, Chronic Kidney Disease, Diabetes Mellitus

Intervention / Treatment
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* Other: non-interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD (renal replacement therapy non excluded) DM CKD+DM Exclusion Criteria: alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CKD<br>chronic kidney disease | Other: non-interventional study<br> <br> |
| DM<br>diabetes mellitus | Other: non-interventional study<br> <br> |
| CKD+DM<br>chronic kidney disease + diabetes mellitus | Other: non-interventional study<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions | The association of hepatic steatosis with chronic kidney disease, diabetes mellitus and the the persence of these two will be assessed | 2 years | 
| Association of genetical factors with NFS and HSI | The association of hepatic steatosis with genetic factors will be assessed. In case of patatin-like phospholipase domain-containing protein 3 gene (PNPLA3) : rs738409, rs2281135, rs2294918 single nuclear polimorfism (SNP) will be examined | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of hepatic steatosis with renal function | The association of serum creatinine, eGFR, blood urea nitrogen, serum sodium, serum potassium, serum calcium with NFS and HSI will be assessed | 2 years | 
| Association of glucose metabolism parameters with hepaic steatosis indices | Association of HbA1C, fructosamine, blood glucose, serum insulin, HOMAIR, serum uric acid with NFS and HSI | 2 years | 
| Association of liver function and hepatic setatosis indices | Association of serum bilirubine, serum GOT, serum GPT, serum GGT, serum ALP, serum LDH, INR, serum total protein, serum albumin with NFS and HSI | 2 years | 
| Association of serum lipid profile and hepatic setatosis indices | Association of serum total cholesterol, serum HDL-cholesterol, serum LDL-cholesterol, serum triglyceride, serum carnitine with NFS and HSI | 2 years | 
| Association of iron metabolism parameters with hepatic setatosis indices | association of serum iron, serum transferrine, serum transferrine saturation, serum ferritine with NFS and HSI | 2 years | 
| The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices | Association of blood count, erythrocyte sedimentation rate, CRP with NFS and HSI | 2 years | 
| Assotion of serum proteins with hepatic setatosis indices | association of urinary total protein, urinary albumin, urinary total protein/creatinine ratio, urinary albumin/creatinine ratio with NFS and HSI | 2 years | 
| Association of pathological tyrosine isoforms with hepatic setatosis indices | Association of serum meta-Tyr, serum ortho-Tyr, urinary meta-Tyr, urinary ortho-Tyr, urinary meta-Tyr/creatinine ratio, urinary ortho-Tyr/creatinine ratio with NFS and HSI | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-alcoholic Fatty Liver Disease, Chronic Kidney Disease, Diabetes Mellitus, Cross-sectional