Liver DiseasesNCT03172650
Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions
An observational study of Liver Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- glomerular filtration rate
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to Sep 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited outpatient clinic of internal medicine of Luxor international hospital and Assiut university hospital
Who may be able to join
- All non alcoholic fatty liver disease patients evidenced by abdominal ultrasound.
- Urine analysis whether normal or renal sedimentation.
Who cannot join
- Alcoholic fatty liver patients.
- patients known to have diabetes mellitus.
- patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune.
- patients known to have kidney disease.
- Hypertension.
- Hyperuricemia.
- Impaired urea and creatinine patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abbas
Assiut, Cairo Governorate, 002
ahmed abbas, MD, bmr90@hotmail.com
ahmed abbas
About this study
Official title: Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions: Observational Case Control Study in Upper Egypt
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.
- Conditions
- Liver Diseases
- Being tested
- glomerular filtration rate
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glomerular filtration rateDiagnostic test
collection of blood sample 5 milliliter for calculation of glomerular filtration rate
| Study group | Role | What they receive |
|---|---|---|
| study group | non alcoholic fatty liver disease patients Receives: Diagnostic Test: glomerular filtration rate | |
| Control group | fatty liver patients Receives: Diagnostic Test: glomerular filtration rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with abnormal laboratory glomerular filtration rate
decreased glomerular filtration rate <60 mL/minute will be considered abnormal
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jul 2017
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172650
- Sponsor's protocol ID
- NAFLD
- Status last verified
- Aug 2017
- First submitted
- 30 May 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-alcoholic Fatty Liver Disease on Kidney Functions: Observational Case Control Study in Upper Egypt
- ClinicalTrials.gov ID
- NCT03172650
- Acronym / sponsor ID
- NAFLD
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Jun 2017 (actual)
- 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.
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: glomerular filtration ratenon alcoholic fatty liver disease patients |
| Control group | – | Diagnostic Test: glomerular filtration ratefatty liver patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited outpatient clinic of internal medicine of Luxor international hospital and Assiut university hospital
Key inclusion criteria (2 listed)
- All non alcoholic fatty liver disease patients evidenced by abdominal ultrasound.
- Urine analysis whether normal or renal sedimentation.
Key exclusion criteria (7 listed)
- Alcoholic fatty liver patients.
- patients known to have diabetes mellitus.
- patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune.
- patients known to have kidney disease.
- Hypertension.
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 |
|---|---|---|
| glomerular filtration ratecollection of blood sample 5 milliliter for calculation of glomerular filtration rate | Diagnostic test | Control group, study group |
Primary outcome
The percentage of patients with abnormal laboratory glomerular filtration rate
Time frame: 1 day
decreased glomerular filtration rate <60 mL/minute will be considered abnormal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- 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.
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 Liver Diseases, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 7 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 16 Aug 2017. 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 Egypt. 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?
Contact Mahmoud Ali, MBBCh (00201144287363, ans1111eg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with abnormal laboratory glomerular filtration rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2017.