Non Alcoholic Fatty Liver DiseaseNCT03276039
Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus
An observational study of Non Alcoholic Fatty Liver Disease, run by Ain Shams University.
Trial summary
This study included 70 subjects divided into 3 groups. Group I included 25 patients with NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20 controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3) was measured using ELISA. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- plasma pentraxin-3
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2014to 30 Jul 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 50 adult Egyptian patients collected from Gastroenterology Unit, Internal Medicine, and Tropical Medicine Departments, were included. Additionally, 20 apparently healthy subjects were included as the control group. They were classified into three groups: Group I: included 25 patients with NAFLD diagnosed by radiological features and by exclusion of other causes of fatty liver. Group II: included 25 patients with radiological features of NAFLD and laboratory evidence of chronic hepatitis C viral infection (positive PCR). Group III: included 20 apparently healthy control subjects with negative medical history, normal physical examination, and normal laboratory and radiological examination.
Who may be able to join
- Patients with NAFLD.
- Patients with NAFLD and chronic hepatitis C viral infection.
Who cannot join
- Current or past consumption of significant amount of alcohol more than 21 drinks and 14 drinks per week for men and women respectively.
- Patients receiving Drugs which cause fatty liver as amiodarone, diliazem, tamoxifen, steroids.
- Patients who take statins as it has lowering effect on plasma PTX3.
- Patients having any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more than two folds the upper limit of normal.
- Patients with heart failure.
- Patients with autoimmune rheumatic disease.
- Patients with chronic kidney diseases.
- Patients with sepsis.
About this study
Official title: Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus: A Comparative Egyptian Study
This study included 70 subjects divided into 3 groups. Group I included 25 patients with NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20 controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3) was measured using ELISA. Comparison between three groups was done regarding plasma pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive test for prediction of metabolic syndrome in the high-risk population with high sensitivity and moderate specificity.
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- plasma pentraxin-3
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma pentraxin-3Diagnostic test
Plasma pentraxin-3 was measured using ELISA
| Study group | Role | What they receive |
|---|---|---|
| 25 patients with non-alcoholic fatty liver disease | Not described Receives: Diagnostic Test: plasma pentraxin-3 | |
| 25 patients with NAFLD and chronic HCV | Not described Receives: Diagnostic Test: plasma pentraxin-3 | |
| 20 healthy controls | Not described Receives: Diagnostic Test: plasma pentraxin-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection
Measurement of plasma pentraxin-3 in patients with NAFLD in comparison to it's levels in patients with hepatic steatosis on top of HCV and normal controls
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start15 Apr 2014
- Primary completion15 Apr 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Abou Bakr Saleh, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276039
- Sponsor's protocol ID
- 456
- Status last verified
- Sep 2017
- First submitted
- 2 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus: A Comparative Egyptian Study
- ClinicalTrials.gov ID
- NCT03276039
- Acronym / sponsor ID
- 456
- Conditions
- Non Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Apr 2014 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 8 Sep 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.
This study included 70 subjects divided into 3 groups. Group I included 25 patients with NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20 controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3) was measured using ELISA. Comparison between three groups was done regarding plasma pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive test for prediction of metabolic syndrome in the high-risk population with high sensitivity and moderate specificity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 patients with non-alcoholic fatty liver disease | – | Diagnostic Test: plasma pentraxin-3 |
| 25 patients with NAFLD and chronic HCV | – | Diagnostic Test: plasma pentraxin-3 |
| 20 healthy controls | – | Diagnostic Test: plasma pentraxin-3 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 adult Egyptian patients collected from Gastroenterology Unit, Internal Medicine, and Tropical Medicine Departments, were included. Additionally, 20 apparently healthy subjects were included as the control group. They were classified into three groups: Group I: included 25 patients with NAFLD diagnosed by radiological features and by exclusion of other causes of fatty liver. Group II: included 25 patients with radiological features of NAFLD and laboratory evidence of chronic hepatitis C viral infection (positive PCR). Group III: included 20 apparently healthy control subjects with negative medical history, normal physical examination, and normal laboratory and radiological examination.
Key inclusion criteria (2 listed)
- Patients with NAFLD.
- Patients with NAFLD and chronic hepatitis C viral infection.
Key exclusion criteria (8 listed)
- Current or past consumption of significant amount of alcohol more than 21 drinks and 14 drinks per week for men and women respectively.
- Patients receiving Drugs which cause fatty liver as amiodarone, diliazem, tamoxifen, steroids.
- Patients who take statins as it has lowering effect on plasma PTX3.
- Patients having any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more than two folds the upper limit of normal.
- Patients with heart failure.
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 |
|---|---|---|
| plasma pentraxin-3Plasma pentraxin-3 was measured using ELISA | Diagnostic test | 20 healthy controls, 25 patients with NAFLD and chronic HCV, 25 patients with non-alcoholic fatty liver disease |
Primary outcome
Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection
Time frame: 1 year
Measurement of plasma pentraxin-3 in patients with NAFLD in comparison to it's levels in patients with hepatic steatosis on top of HCV and normal controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Alcoholic Fatty Liver Disease, run by Ain Shams University.
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 8 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: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma pentraxin-3 as a non invasive diagnostic marker in diagnosis of NAFLD in comparison to it's levels in patients with NAFLD and chronic hepatitis C viral infection (time frame: 1 year). 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 8 Sep 2017.