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

• Conditions: Non-alcoholic Fatty Liver Disease; Chronic Kidney Disease; Diabetes Mellitus
• Interventions: Other: non-interventional study

• Registration Number: NCT02947568
• Lead Sponsor: University of Pecs

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• CKD (renal replacement therapy non excluded)
• DM
• CKD+DM

Exclusion Criteria

• alcohol abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD	non-interventional study	chronic kidney disease
DM	non-interventional study	diabetes mellitus
CKD+DM	non-interventional study	chronic kidney disease + diabetes mellitus

Primary Outcome Measures

Name	Time	Method
Association of genetical factors with NFS and HSI	2 years	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
Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions	2 years	The association of hepatic steatosis with chronic kidney disease, diabetes mellitus and the the persence of these two will be assessed

Secondary Outcome Measures

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

Trial Locations

Locations (1)

2nd Department of Medicine and Nephrological Center; 🇭🇺 Pécs, Baranya, Hungary