Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02947568
Acronym
NAFLDDMCKD
Enrollment
600
Registered
2016-10-28
Start date
2016-03-31
Completion date
2020-12-31
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Non-alcoholic Fatty Liver Disease, Chronic Kidney Disease, Diabetes Mellitus, Cross-sectional

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).

Interventions

OTHERnon-interventional study

Sponsors

Teaching Hospital Markusovszky, Szombathely
CollaboratorUNKNOWN
Fresenius Medical Care North America
CollaboratorINDUSTRY
University of Pecs
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* alcohol abuse

Design outcomes

Primary

MeasureTime frameDescription
Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions2 yearsThe association of hepatic steatosis with chronic kidney disease, diabetes mellitus and the the persence of these two will be assessed
Association of genetical factors with NFS and HSI2 yearsThe 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

Secondary

MeasureTime frameDescription
Association of liver function and hepatic setatosis indices2 yearsAssociation of serum bilirubine, serum GOT, serum GPT, serum GGT, serum ALP, serum LDH, INR, serum total protein, serum albumin with NFS and HSI
Association of serum lipid profile and hepatic setatosis indices2 yearsAssociation of serum total cholesterol, serum HDL-cholesterol, serum LDL-cholesterol, serum triglyceride, serum carnitine with NFS and HSI
Association of iron metabolism parameters with hepatic setatosis indices2 yearsassociation of serum iron, serum transferrine, serum transferrine saturation, serum ferritine with NFS and HSI
Association of hepatic steatosis with renal function2 yearsThe association of serum creatinine, eGFR, blood urea nitrogen, serum sodium, serum potassium, serum calcium with NFS and HSI will be assessed
Assotion of serum proteins with hepatic setatosis indices2 yearsassociation of urinary total protein, urinary albumin, urinary total protein/creatinine ratio, urinary albumin/creatinine ratio with NFS and HSI
Association of pathological tyrosine isoforms with hepatic setatosis indices2 yearsAssociation 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
The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices2 yearsAssociation of blood count, erythrocyte sedimentation rate, CRP with NFS and HSI
Association of glucose metabolism parameters with hepaic steatosis indices2 yearsAssociation of HbA1C, fructosamine, blood glucose, serum insulin, HOMAIR, serum uric acid with NFS and HSI

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026