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

NCT02947568 | Unknown

• 1 other identifier: Pecs_NAFLD_01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Association of hepatic steatosis with renal function

  2 years

• Association of glucose metabolism parameters with hepaic steatosis indices

  2 years

• Association of liver function and hepatic setatosis indices

  2 years

• Association of serum lipid profile and hepatic setatosis indices

  2 years

• Association of iron metabolism parameters with hepatic setatosis indices

  2 years

Study Arms (3)

CKD

chronic kidney disease

Other: non-interventional study

DM

diabetes mellitus

Other: non-interventional study

CKD+DM

chronic kidney disease + diabetes mellitus

Other: non-interventional study

Interventions

non-interventional study OTHER

CKD; CKD+DM; DM

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• alcohol abuse

Sponsors & Collaborators

• University of Pecs: lead
• Teaching Hospital Markusovszky, Szombathely: collaborator
• Fresenius Medical Care North America: collaborator

Study Sites (1)

2nd Department of Medicine and Nephrological Center

Pécs, Baranya, 7624, Hungary

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Renal Insufficiency, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: October 28, 2016
• Study Start: March 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)