Non-Alcoholic Fatty Liver DiseaseNCT05106049
Serum Adiponectin as an Early Marker for Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease.
An observational study of Non-Alcoholic Fatty Liver Disease, run by Assiut University.
Trial summary
Early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum Adiponectin level. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- serum Adiponectin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Jan 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: cases are Non-alcoholic fatty liver patients who do not having any other health problem. control group is healthy individuals.
Who may be able to join
- Patients with fatty liver aged from 18 to 60 yrs either diabetic or not .
- Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2.
- The Control group are completely healthy subjects without any systemic or liver and kidney affection
Who cannot join
- Patients less than 18 yrs \& more than 60 yrs .
- All patients having any other causes of renal and hepatic disease rather than Diabetes and having any other systemic problem.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Detection of Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease by Measuring Serum Adiponectin Level.
Early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.
Read the detailed description
Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- serum Adiponectin
- 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.
serum AdiponectinDiagnostic test
serum adiponectin as early marker for renal impairment. Adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions.
| Study group | Role | What they receive |
|---|---|---|
| cases | non-alcoholic fatty liver patients Receives: Diagnostic Test: serum Adiponectin | |
| control | healthy persons Receives: Diagnostic Test: serum Adiponectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease.
measure level of serum Adiponectin in non-alcoholic fatty liver patients to detect early renal impairment.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (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.
- 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
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Abdelrheem Ahmed, Assiut University
- Investigators
- Mohamed Hassan, Profissor.as, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106049
- Sponsor's protocol ID
- Adiponectin in NAFLD
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stefan N, Stumvoll M. Adiponectin--its role in metabolism and beyond. Horm Metab Res. 2002 Sep;34(9):469-74. doi: 10.1055/s-2002-34785.
PubMed 12384822
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease by Measuring Serum Adiponectin Level.
- ClinicalTrials.gov ID
- NCT05106049
- Acronym / sponsor ID
- Adiponectin in NAFLD
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 3 Nov 2021 (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.
Early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.
Detailed description
Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: serum Adiponectinnon-alcoholic fatty liver patients |
| control | – | Diagnostic Test: serum Adiponectinhealthy persons |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- cases are Non-alcoholic fatty liver patients who do not having any other health problem. control group is healthy individuals.
Key inclusion criteria (3 listed)
- Patients with fatty liver aged from 18 to 60 yrs either diabetic or not .
- Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2.
- The Control group are completely healthy subjects without any systemic or liver and kidney affection
Key exclusion criteria (2 listed)
- Patients less than 18 yrs \& more than 60 yrs .
- All patients having any other causes of renal and hepatic disease rather than Diabetes and having any other systemic problem.
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 |
|---|---|---|
| serum Adiponectinserum adiponectin as early marker for renal impairment. Adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions. | Diagnostic test | cases, control |
Primary outcome
Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease.
Time frame: baseline
measure level of serum Adiponectin in non-alcoholic fatty liver patients to detect early renal impairment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Results publication: PubMed 12384822Stefan N, Stumvoll M. Adiponectin--its role in metabolism and beyond. Horm Metab Res. 2002 Sep;34(9):469-74. doi: 10.1055/s-2002-34785.
- 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.
Mohamed Hassan, Profissor.as study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Assiut 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 3 inclusion and 2 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 3 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend Abdelrheem, Resident (01011062442, hendabdelrheem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease. (time frame: baseline). 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 NCT05106049, 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 3 Nov 2021.