Non-alcoholic Fatty Liver DiseaseNAFLDDMCKDNCT02947568
Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease
An observational study of Non-alcoholic Fatty Liver Disease and Chronic Kidney Disease, run by University of Pecs at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Chronic Kidney Disease, Diabetes Mellitus
- What is being tested?
- non-interventional study
- How many people
- 600 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD without DM, or patients with DM without CKD, or patients with both CKD and DM, aged 18-90
Who may be able to join
- CKD (renal replacement therapy non excluded)
- DM
- CKD+DM
Who cannot join
- alcohol abuse
Trial locations and contacts
1 site in 1 country.
Hungary1 site
2nd Department of Medicine and Nephrological Center
Pécs, Baranya, 7624
About this study
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.
Read the 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).
- Being tested
- non-interventional study
- Keywords
- Non-alcoholic Fatty Liver Disease, Chronic Kidney Disease, Diabetes Mellitus, Cross-sectional
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventional studyOther
| Study group | Role | What they receive |
|---|---|---|
| CKD | chronic kidney disease Receives: Other: non-interventional study | |
| DM | diabetes mellitus Receives: Other: non-interventional study | |
| CKD+DM | chronic kidney disease + diabetes mellitus Receives: Other: non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years
Secondary outcomes (8)
Association of hepatic steatosis with renal function
The association of serum creatinine, eGFR, blood urea nitrogen, serum sodium, serum potassium, serum calcium with NFS and HSI will be assessed
Measured: 2 years
Association of glucose metabolism parameters with hepaic steatosis indices
Association of HbA1C, fructosamine, blood glucose, serum insulin, HOMAIR, serum uric acid with NFS and HSI
Measured: 2 years
Association of liver function and hepatic setatosis indices
Association of serum bilirubine, serum GOT, serum GPT, serum GGT, serum ALP, serum LDH, INR, serum total protein, serum albumin with NFS and HSI
Measured: 2 years
Association of serum lipid profile and hepatic setatosis indices
Association of serum total cholesterol, serum HDL-cholesterol, serum LDL-cholesterol, serum triglyceride, serum carnitine with NFS and HSI
Measured: 2 years
Association of iron metabolism parameters with hepatic setatosis indices
association of serum iron, serum transferrine, serum transferrine saturation, serum ferritine with NFS and HSI
Measured: 2 years
The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices
Association of blood count, erythrocyte sedimentation rate, CRP with NFS and HSI
Measured: 2 years
Assotion of serum proteins with hepatic setatosis indices
association of urinary total protein, urinary albumin, urinary total protein/creatinine ratio, urinary albumin/creatinine ratio with NFS and HSI
Measured: 2 years
Association of pathological tyrosine isoforms with hepatic setatosis indices
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startMar 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- Teaching Hospital Markusovszky, Szombathely, Fresenius Medical Care North America
- Responsible party
- Principal investigator, Dr. Gergő Molnár, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947568
- Sponsor's protocol ID
- Pecs_NAFLD_01
- Acronym
- NAFLDDMCKD
- Status last verified
- Feb 2019
- First submitted
- 22 Sep 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02947568
- Acronym / sponsor ID
- NAFLDDMCKD / Pecs_NAFLD_01
- Keywords
- Non-alcoholic Fatty Liver Disease, Chronic Kidney Disease, Diabetes Mellitus, Cross-sectional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- Teaching Hospital Markusovszky, Szombathely, Fresenius Medical Care North America
- Study start
- Mar 2016
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD | – | Other: non-interventional studychronic kidney disease |
| DM | – | Other: non-interventional studydiabetes mellitus |
| CKD+DM | – | Other: non-interventional studychronic kidney disease + diabetes mellitus |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD without DM, or patients with DM without CKD, or patients with both CKD and DM, aged 18-90
Key inclusion criteria (3 listed)
- CKD (renal replacement therapy non excluded)
- DM
- CKD+DM
Key exclusion criteria (1 listed)
- alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventional study | Other | CKD, CKD+DM, DM |
Primary outcome
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
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
8 secondary outcomes
Association of hepatic steatosis with renal function
Time frame: 2 years
Association of glucose metabolism parameters with hepaic steatosis indices
Time frame: 2 years
Association of liver function and hepatic setatosis indices
Time frame: 2 years
Association of serum lipid profile and hepatic setatosis indices
Time frame: 2 years
Association of iron metabolism parameters with hepatic setatosis indices
Time frame: 2 years
The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices
Time frame: 2 years
Assotion of serum proteins with hepatic setatosis indices
Time frame: 2 years
Association of pathological tyrosine isoforms with hepatic setatosis indices
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Background1. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease and Chronic Kidney Disease, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.