Renal ImpairmentNCT05556135
Role Of Serum Adiponectin In The Ealy Detection Of Renal Impairment In Patients With Non Alcoholic Fatty Liver Disease
An observational study of Renal Impairment, 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
- Renal Impairment
- What is being tested?
- level of serun adiponectin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to Oct 2023
- How long will I take part?
- 1 Year
- 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
- Adult
Study population: All patients who fulfil inclusion and exclusion criteria then directed to nephrology unit to do other full investigations ,will be included in this study . 1)Full history and clinical examination .2) Investigation : * All patients will be investigated for detection of renal impairment by : 1)microalbuminurea. * 2)Urine analyses. * 3)Kidney function tests. * 4)calculate GFR. * 5)Complete blood count . * And also to detect the degree of liver affection by: * 1)liver function tests . * 2)abdominal ultrasound to grade fatty liver \& determine echogenicity of kidney . * 3)Non-invasive blood test to detect degree of hepatic steatosis ( FIB-4 , APRI, fibrosis score ). 4)fibroscane . * Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA *Investigations to control risk factors of Non-alcoholic fatty liver disease: -Calculate Body Mass Index (BMI). - Measuring the fasting blood sugar and HbA1C level in all subjects. -Lipid Profile.
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
- 1)Patients less than 18 yrs \& more than 60 yrs 2)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
Early detection of renal impairment in patients with Non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) includes different types of liver damage, ranging from simple steatosis and nonalcoholic steatohepatitis (NASH) to liver cirrhosis and even hepatocellular carcinoma.(1) NAFLD is diagnosed by the presence of more than 5% fat accumulation in liver cells after excluding excessive alcohol intake in patients as well as other secondary causes of liver disease, such as drug-induced liver injury, viral and autoimmune hepatitis.(2) The diagnostic criteria for chronic kidney disease (CKD) are either the reduced estimated glomerular filtration rate (eGFR) (<60 mL/min/1.732) and/or abnormal albuminuria and/or overt proteinuria in patients for at least 3 months.(3) The association between NAFLD and CKD has recently attracted the attention of many experts. NAFLD and CKD share some common pathophysiological mechanisms as well as some metabolic risk factors for cardiovascular disease. Some studies have confirmed that the presence of NAFLD increases the risk of CKD and that the degree of liver fibrosis is related to CKD stage,(4) It is crucial to detect early renal impairment in patients with NAFLD to prevent CKD progression, minimize complications, and improve survival (1) Adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions.(4) Adiponectin is one of the key regulators involved in glucose and lipid metabolism. Further analyses have shown its anti-inflammatory and anti-apoptotic roles in human cells.
Data from large cross sectional studies showed a positive correlation between serum Adiponectin and mortality in chronic kidney disease.(5)
- Conditions
- Renal Impairment
- Being tested
- level of serun adiponectin
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level of serun adiponectinDiagnostic test
estimation of level of serum adiponectin in NAFLD for early detection of renal impairement
| Study group | Role | What they receive |
|---|---|---|
| group1 | NAFLD patients Receives: Diagnostic Test: level of serun adiponectin | |
| group 2 | non NAFLD patients Receives: Diagnostic Test: level of serun 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.
Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease. /
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Abdelrafe Sayed, Assiut University
- Investigators
- mohamed hassan, MD, Study director, master
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556135
- Sponsor's protocol ID
- Serum Adiponectin in NAFLD
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Montesano R, Orci L, Vassalli P. In vitro rapid organization of endothelial cells into capillary-like networks is promoted by collagen matrices. J Cell Biol. 1983 Nov;97(5 Pt 1):1648-52. doi: 10.1083/jcb.97.5.1648.
PubMed 6630296Stefan 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 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Serum Adiponectin In The Ealy Detection Of Renal Impairment In Patients With Non Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05556135
- Acronym / sponsor ID
- Serum Adiponectin in NAFLD
- Conditions
- Renal Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 27 Sep 2022 (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
Nonalcoholic fatty liver disease (NAFLD) includes different types of liver damage, ranging from simple steatosis and nonalcoholic steatohepatitis (NASH) to liver cirrhosis and even hepatocellular carcinoma.(1) NAFLD is diagnosed by the presence of more than 5% fat accumulation in liver cells after excluding excessive alcohol intake in patients as well as other secondary causes of liver disease, such as drug-induced liver injury, viral and autoimmune hepatitis.(2) The diagnostic criteria for chronic kidney disease (CKD) are either the reduced estimated glomerular filtration rate (eGFR) (<60 mL/min/1.732) and/or abnormal albuminuria and/or overt proteinuria in patients for at least 3 months.(3) The association between NAFLD and CKD has recently attracted the attention of many experts. NAFLD and CKD share some common pathophysiological mechanisms as well as some metabolic risk factors for cardiovascular disease. Some studies have confirmed that the presence of NAFLD increases the risk of CKD and that the degree of liver fibrosis is related to CKD stage,(4) It is crucial to detect early renal impairment in patients with NAFLD to prevent CKD progression, minimize complications, and improve survival (1) Adiponectin is a recently identified adipose tissue-derived protein (adipocytokine) with important metabolic ,antiinflammatory, anti-atherogenic, and reactive oxygen species protective actions.(4) Adiponectin is one of the key regulators involved in glucose and lipid metabolism. Further analyses have shown its anti-inflammatory and anti-apoptotic roles in human cells.
Data from large cross sectional studies showed a positive correlation between serum Adiponectin and mortality in chronic kidney disease.(5)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1 | – | Diagnostic Test: level of serun adiponectinNAFLD patients |
| group 2 | – | Diagnostic Test: level of serun adiponectinnon NAFLD patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- All patients who fulfil inclusion and exclusion criteria then directed to nephrology unit to do other full investigations ,will be included in this study . 1)Full history and clinical examination .2) Investigation : * All patients will be investigated for detection of renal impairment by : 1)microalbuminurea. * 2)Urine analyses. * 3)Kidney function tests. * 4)calculate GFR. * 5)Complete blood count . * And also to detect the degree of liver affection by: * 1)liver function tests . * 2)abdominal ultrasound to grade fatty liver \& determine echogenicity of kidney . * 3)Non-invasive blood test to detect degree of hepatic steatosis ( FIB-4 , APRI, fibrosis score ). 4)fibroscane . * Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA *Investigations to control risk factors of Non-alcoholic fatty liver disease: -Calculate Body Mass Index (BMI). - Measuring the fasting blood sugar and HbA1C level in all subjects. -Lipid Profile.
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 (1 listed)
- 1)Patients less than 18 yrs \& more than 60 yrs 2)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 |
|---|---|---|
| level of serun adiponectinestimation of level of serum adiponectin in NAFLD for early detection of renal impairement | Diagnostic test | group 2, group1 |
Primary outcome
Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease.
Time frame: baseline
Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease. /
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 6630296Montesano R, Orci L, Vassalli P. In vitro rapid organization of endothelial cells into capillary-like networks is promoted by collagen matrices. J Cell Biol. 1983 Nov;97(5 Pt 1):1648-52. doi: 10.1083/jcb.97.5.1648.
- Background: 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.
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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, MD study director
master
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Impairment, 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 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 27 Sep 2022. 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 Mustafa Abdelrafie, master (01010303737, mustafabadary@yahoo.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 NCT05556135, which also lists 2 linked publications.
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 27 Sep 2022.