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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05556135
Other study ID # Serum Adiponectin in NAFLD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date October 2023

Study information

Verified date September 2022
Source Assiut University
Contact Mustafa Abdelrafie, master
Phone 01010303737
Email mustafabadary@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Early detection of renal impairment in patients with Non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Patients with fatty liver aged from 18 to 60 yrs either diabetic or not . 2. Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2. 3. The Control group are completely healthy subjects without any systemic or liver and kidney affection Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
level of serun adiponectin
estimation of level of serum adiponectin in NAFLD for early detection of renal impairement

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. — View Citation

Stefan N, Stumvoll M. Adiponectin--its role in metabolism and beyond. Horm Metab Res. 2002 Sep;34(9):469-74. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. / baseline
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