Transient Elastograghy to Detect Non Alcoholic Fatty Liver Disease in Renal Transplantation Recipients.

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Transient Elastograghy to Detect NAFLD in RTRs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05894993
• Other study ID #: NAFLD in RTRs
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: Amany khaled Ahmed, master
• Phone: +201122620076
• Email: amany.khaled91[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

a. Primary (main): The presence of non alcoholic fatty liver disease in post renal transplantation recipients by non invasive methods as transient elastograghy b-Secondary (subsidiary): to evaluate if transient elastograghy could be used as a noninvasive tool as new perspective on the prediction, prevention of non alcoholic fatty liver disease in renal trasplantation recipients .

Description:

. Nonalcoholic fatty liver disease is caused by an accumulation of fat in the liver in the absence of significant alcohol intake. Nonalcoholic fatty liver disease is the most common chronic liver disorder. Chronic kidney disease defined as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1•73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause. Nonalcoholic fatty liver disease (and chronic kidney disease constitute a global public health problem, affecting approximately 25% and 10% of the world population, respectively. In recent years, both Nonalcoholic fatty liver disease and chronic kidney disease have shown increasing incidences. Renal transplantation has significantly improved the survival of patients with end-stage renal disease (ESRD). Despite major advancements in immunosuppressive treatment of renal transplant recipients (RTR) that significantly increased graft and patient short-term survival and lowered the incidence of rejection crises, long-term prognosis is still poor. ., Immunosuppressive drugs used in renal trasplantation increase incidence and severity of traditional cardiovascular risk factors and thus have expected effects on components of the metabolic syndrome (MS) after kidney transplantation. Other Common factors underlying the pathogenesis of and chronic allograft dysfunction may be insulin resistance, oxidative stress, activation of rennin-angiotensin system , Dyslipidemia, and inappropriate secretion of inflammatory cytokines by stereogenic and inflamed liver. NAFLD represents a liver manifestation of metabolic syndrome and it development is strongly associated with all components of MS in general population. They propose that the presence of NAFLD in RTR could be a strong predictor in cardiovascular morbidity and mortality., Wang H, Lin ZT, Yuan Y, Wu T. hypothesis that non alcoholic fatty liver disease may be associated with deteriorating graft function, causing a chronic allograft nephropathy and graft loss. Due to the high rate of corticosteroid askwith considering the strong relationship between chronic kidney disease and NAFLD, NAFLD would probably be a common disorder among kidney transplantation recipients if these patients did not receive stereogenic medications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• • a. Inclusion criteria: All renal transplant recipients with a functioning graft for more than 1 year coming for follow up at renal outpatient clinics in Assiut university hospitals .
• Trough level of immunosuppressive drugs .

Exclusion Criteria:

• Patients are excluded for participation in the study if
• chronic hepatitis B and/or C virus infection,
• CMV infections
• Chronic liver disease
• presence of other autoimmune or cholestatic liver disease,
• drug induced liver disorder
• excessive alcohol abuse,
• pregnancy
• malignancy
• dyslipidemia, bleeding tendency ,
• Renal rejections .

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Device:
• transient elastograghy
is a non-invasive method proposed for the assessment of hepatic fibrosis in patients with chronic liver disease by measuring liver stiffness. It can be easily performed at the bedside or in the outpatients clinic with immediate results and good reproducibility.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amany Khaled Ali Ahmed

References & Publications (1)

Gahm C, Park S. The association between skipping breakfast and chronic kidney disease. Int Urol Nephrol. 2023 Apr 24. doi: 10.1007/s11255-023-03590-5. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	): The presence of NAFLD in post renal transplantation recipients by non invasive methods as transient elastograghy.	): to evaluate if transient elastograghy could be used as a noninvasive tool as new perspective on the prediction, prevention of non alcoholic fatty liver desease in renal trasplantation recipients .	Degree of hepatic fibroses from f0-f4,Degree of steatosis "through study completion, an average of 1 year"