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

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ClinicalTrials.gov Identifier: NCT02947568
Recruitment Status : Unknown
Verified February 2019 by Dr. Gergő Molnár, University of Pecs.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2016
Last Update Posted : February 25, 2019
Sponsor:
Collaborators:
Teaching Hospital Markusovszky, Szombathely
Fresenius Medical Care North America
Information provided by (Responsible Party):
Dr. Gergő Molnár, University of Pecs

Study Description
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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.

Condition or disease Intervention/treatment
Non-alcoholic Fatty Liver Disease Chronic Kidney Disease Diabetes Mellitus Other: non-interventional study

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 Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease
Study Start Date : March 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions [ Time Frame: 2 years ]
    The association of hepatic steatosis with chronic kidney disease, diabetes mellitus and the the persence of these two will be assessed

  2. Association of genetical factors with NFS and HSI [ Time Frame: 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


Secondary Outcome Measures :
  1. Association of hepatic steatosis with renal function [ Time Frame: 2 years ]
    The association of serum creatinine, eGFR, blood urea nitrogen, serum sodium, serum potassium, serum calcium with NFS and HSI will be assessed

  2. Association of glucose metabolism parameters with hepaic steatosis indices [ Time Frame: 2 years ]
    Association of HbA1C, fructosamine, blood glucose, serum insulin, HOMAIR, serum uric acid with NFS and HSI

  3. Association of liver function and hepatic setatosis indices [ Time Frame: 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

  4. Association of serum lipid profile and hepatic setatosis indices [ Time Frame: 2 years ]
    Association of serum total cholesterol, serum HDL-cholesterol, serum LDL-cholesterol, serum triglyceride, serum carnitine with NFS and HSI

  5. Association of iron metabolism parameters with hepatic setatosis indices [ Time Frame: 2 years ]
    association of serum iron, serum transferrine, serum transferrine saturation, serum ferritine with NFS and HSI

  6. The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices [ Time Frame: 2 years ]
    Association of blood count, erythrocyte sedimentation rate, CRP with NFS and HSI

  7. Assotion of serum proteins with hepatic setatosis indices [ Time Frame: 2 years ]
    association of urinary total protein, urinary albumin, urinary total protein/creatinine ratio, urinary albumin/creatinine ratio with NFS and HSI

  8. Association of pathological tyrosine isoforms with hepatic setatosis indices [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • alcohol abuse
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947568


Locations
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Hungary
2nd Department of Medicine and Nephrological Center
Pécs, Baranya, Hungary, 7624
Sponsors and Collaborators
University of Pecs
Teaching Hospital Markusovszky, Szombathely
Fresenius Medical Care North America
More Information
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Publications:
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.

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Responsible Party: Dr. Gergő Molnár, MD, University of Pecs
ClinicalTrials.gov Identifier: NCT02947568    
Other Study ID Numbers: Pecs_NAFLD_01
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Gergő Molnár, University of Pecs:
Non-alcoholic Fatty Liver Disease
Chronic Kidney Disease
Diabetes Mellitus
Cross-sectional
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Digestive System Diseases