Clinical trial NCT02947568: Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease
Official title: Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease
Chronic Kidney Disease
Diabetes Mellitus
Keywords: Non-alcoholic Fatty Liver Disease
Chronic Kidney Disease
Diabetes Mellitus
Cross-sectional
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Teaching Hospital Markusovszky, Szombathely
name: Fresenius Medical Care North America
First posted: 2016-10-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CKD without DM, or patients with DM without CKD, or patients with both CKD and DM, aged 18-90

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* alcohol abuse

Primary outcomes:
measure: Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions
timeFrame: 2 years
measure: Association of genetical factors with NFS and HSI
timeFrame: 2 years
Secondary outcomes:
measure: Association of hepatic steatosis with renal function
timeFrame: 2 years
measure: Association of glucose metabolism parameters with hepaic steatosis indices
timeFrame: 2 years
measure: Association of liver function and hepatic setatosis indices
timeFrame: 2 years
measure: Association of serum lipid profile and hepatic setatosis indices
timeFrame: 2 years
measure: Association of iron metabolism parameters with hepatic setatosis indices
timeFrame: 2 years
measure: The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices
timeFrame: 2 years
measure: Assotion of serum proteins with hepatic setatosis indices
timeFrame: 2 years
measure: Association of pathological tyrosine isoforms with hepatic setatosis indices
timeFrame: 2 years
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: 2nd Department of Medicine and Nephrological Center
state: Baranya
Study officials:
References:
citation: 1. Alp H, Karaarsian S, Selver EB,Atabek ME, Altin H, Baysal T. Association between nonalcoholic fatty liver disease and cardiovascular risk in obese children and adolescents. Can J Cardiol 2013;29:1118-1125. 2. Byrne CD, Targher G: NAFLD: A multisystem disease. Review. Journal of Hepatology, 2015; 62:S47-S64. 3. Kasturiratne A, Weerasinghe S, Dassanayake AS, rajindrajith S, de Silva AP, Kato N, et al. Influence of non-alcoholic fatty liver disease on the development of diabetes mellitus. J Gastroenterol Hepatol 2013;60:384-391. 4. Li G, Shi W, Hug H, Chen Y, Liu L, Yin D. Nonalcoholic fatty liver disease associated with impairment of kidney function in nondiabetes population. Biochem Med 2012;22:92-99. 5. Okamoto M, Takeda Y, Yoda Y, Kobayashi K, Fujino MA, Yamagata Z. The association of fatty liver and diabetes risk. J Epidemiol 2003;13:15-21. 6. Pacifico L, Di MM, De MA, Bezzi M, Osborn JF, Catalano C, et al. Left ventricular dysfunction in obese children and adolescents with nonalcoholic fatty liver disease. Hepatology 2014;59:461-470. 7. Targher G, Choncol MB, Byrne CD. CKD a nonalcoholic fatty liver disease. Am J Kidney Dis 2014;64:638-652. 8. Wood KL, Miller MH, Dillon JF. systematic review of genetic association studies involving histologically confirmed non-alcoholic fatty liver disease BMJ Open Gastro 2015:2:e000019. doi10.1136/bmjgast-2014-000019 9. Zain SM, Mohamed R, Hyogo H, et al. A multi-ethnic study of a PNPLA3 variant and its association with disease severity in non-alcoholic fatty liver disease. Hum genet 2012;131:1145-1152. 10. Zuppini G, Fedeli U, Gennaro N, Saugo M, Targher G, Bonora E. Mortality from chronic liver diseases in diabetes. Am J Gastroenterol 2014;109:1020-1025.