Study Results
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Basic Information
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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2024-01-31
2025-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Abdallah Gamal Abd El Hafeez Haridy
Resident
Principal Investigators
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Essam Abdelmonem Sadek, Prof
Role: STUDY_DIRECTOR
Assiut University
Mohamed Hassan Mustafa, Dr
Role: STUDY_DIRECTOR
Assiut University
Abdallah Gamal Abd El Hafeez, Resident
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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;73(3):182-189. doi: 10.24875/RIC.20000534.
Other Identifiers
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Fib to Alb ratio
Identifier Type: -
Identifier Source: org_study_id
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