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NCT05691985 Clinical Trial

Fib to Alb Ratio in Type 2 Dkd

Type 2 Diabetes Clinical Trial

Official title:
Fibrinogen to Albumin Ratio (FAR) as a Risk Factor for Type 2 Diabetic Nephropathy(DN)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05691985
Other study ID # Fib to Alb ratio
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2024
Est. completion date February 2025

Study information
Verified date January 2024
Source Assiut University
Contact Abdallah Gamal Abd El Hafeez, Resident
Phone 01221248314
Email memo_star440@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Aimed to investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2 and to prove its possible role as a novel biomarker to predict and prevent DKD progression.

Description:

Diabetic kidney disease (DKD) is the most prevalent chronic kidney disease. Around 3540% of patients with type 2 diabetes mellitus (T2DM) will go on to develop DKD. DKD is characterized by albuminuria and reduced estimated glomerular filtration rate (eGFR), both of which are independent risk factors for end-stage kidney disease (ESKD), cardiovascular events, and death. DKD accounts for a significant increase in mortality among diabetic patients and is a grave threat to their clinical outcome. Inflammation plays a major role in the development of DKD. Serum fibrinogen (FIB) is a biomarker of coagulation and inflammation. Elevated serum FIB is an independent risk factor of DKD progression to ESKD in patients with T2DM. Albumin (ALB) has anti-inflammatory functions and antioxidant properties. Hypoalbuminemia is associated with a poorer renal prognosis in patients with T2DM and DKD. Fibrinogen to albumin ratio (FAR) is a more significant prognostic marker than each single marker itself in cancer study.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date February 2025
Est. primary completion date March 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age above 18 yrs. - 50 Pts with type 2 DM that have DKD (presence of albuminuria in association with diabetic retinopathy) and 50 pts with type 2 DM but have no DKD. Exclusion Criteria: - Age below 18 yrs. - Pts with ESKD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DKA and Cancer. - Pt who refused to contribute in this study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (15)

American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. doi: 10.2337/dc18-S002. — View Citation

Berhane AM, Weil EJ, Knowler WC, Nelson RG, Hanson RL. Albuminuria and estimated glomerular filtration rate as predictors of diabetic end-stage renal disease and death. Clin J Am Soc Nephrol. 2011 Oct;6(10):2444-51. doi: 10.2215/CJN.00580111. Epub 2011 Aug 18. — View Citation

Erdogan G, Arslan U, Yenercag M, Durmus G, Tugrul S, Sahin I. Relationship Between the Fibrinogen-to-Albumin Ratio and SYNTAX Score in Patients with Non-St-Elevation Myocardial Infarction. Rev Invest Clin. 2021 Feb 3. doi: 10.24875/RIC.20000534. Online ahead of print. — View Citation

GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13. — View Citation

Hsieh JY, Smith TD, Meli VS, Tran TN, Botvinick EL, Liu WF. Differential regulation of macrophage inflammatory activation by fibrin and fibrinogen. Acta Biomater. 2017 Jan 1;47:14-24. doi: 10.1016/j.actbio.2016.09.024. Epub 2016 Sep 20. — View Citation

KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available. — View Citation

Luyendyk JP, Schoenecker JG, Flick MJ. The multifaceted role of fibrinogen in tissue injury and inflammation. Blood. 2019 Feb 7;133(6):511-520. doi: 10.1182/blood-2018-07-818211. Epub 2018 Dec 6. — View Citation

Martinez-Castelao A, Navarro-Gonzalez JF, Gorriz JL, de Alvaro F. The Concept and the Epidemiology of Diabetic Nephropathy Have Changed in Recent Years. J Clin Med. 2015 May 28;4(6):1207-16. doi: 10.3390/jcm4061207. — View Citation

Myrup B, de Maat M, Rossing P, Gram J, Kluft C, Jespersen J. Elevated fibrinogen and the relation to acute phase response in diabetic nephropathy. Thromb Res. 1996 Feb 15;81(4):485-90. doi: 10.1016/0049-3848(96)00021-7. — View Citation

Pan L, Ye Y, Wo M, Bao D, Zhu F, Cheng M, Ni X, Fei X. Clinical Significance of Hemostatic Parameters in the Prediction for Type 2 Diabetes Mellitus and Diabetic Nephropathy. Dis Markers. 2018 Feb 4;2018:5214376. doi: 10.1155/2018/5214376. eCollection 2018. — View Citation

Perez-Morales RE, Del Pino MD, Valdivielso JM, Ortiz A, Mora-Fernandez C, Navarro-Gonzalez JF. Inflammation in Diabetic Kidney Disease. Nephron. 2019;143(1):12-16. doi: 10.1159/000493278. Epub 2018 Oct 1. — View Citation

Sorensen I, Susnik N, Inhester T, Degen JL, Melk A, Haller H, Schmitt R. Fibrinogen, acting as a mitogen for tubulointerstitial fibroblasts, promotes renal fibrosis. Kidney Int. 2011 Nov;80(10):1035-44. doi: 10.1038/ki.2011.214. Epub 2011 Jul 6. — View Citation

Tessari P, Kiwanuka E, Barazzoni R, Vettore M, Zanetti M. Diabetic nephropathy is associated with increased albumin and fibrinogen production in patients with type 2 diabetes. Diabetologia. 2006 Aug;49(8):1955-61. doi: 10.1007/s00125-006-0288-2. Epub 2006 May 16. — View Citation

Zhang J, Wang Y, Zhang R, Li H, Han Q, Wu Y, Wang S, Guo R, Wang T, Li L, Liu F. Serum fibrinogen predicts diabetic ESRD in patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2018 Jul;141:1-9. doi: 10.1016/j.diabres.2018.04.025. Epub 2018 Apr 21. — View Citation

Zhang J, Zhang R, Wang Y, Li H, Han Q, Wu Y, Wang T, Liu F. The Level of Serum Albumin Is Associated with Renal Prognosis in Patients with Diabetic Nephropathy. J Diabetes Res. 2019 Feb 17;2019:7825804. doi: 10.1155/2019/7825804. eCollection 2019. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary The association of fibrinogen to albumin ratio (FAR) with DKD type 2. investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2. baseline
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