NCT05691985

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 11, 2023

Last Update Submit

January 14, 2024

Conditions

CKDType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are selected on criteria of all genders, age above 18, type 2 DM and CKD. Patients are selected from clinics, community and pts admitted at hospital.

You may qualify if:

  • Age above 18 yrs.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 30273931BACKGROUND

  • 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.

    PMID: 32061315BACKGROUND

  • 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.

    PMID: 26239554BACKGROUND

  • 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.

    PMID: 21852671BACKGROUND

  • 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.

    PMID: 30523120BACKGROUND

  • 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.

    PMID: 27662809BACKGROUND

  • 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.

    PMID: 29684616BACKGROUND

  • 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.

    PMID: 30911552BACKGROUND

  • 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.

    PMID: 29222373BACKGROUND

  • 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.

    PMID: 17276798BACKGROUND

  • 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.

    PMID: 21734641BACKGROUND

  • 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.

    PMID: 8907298BACKGROUND

  • 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.

    PMID: 29511389BACKGROUND

  • 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.

    PMID: 16703327BACKGROUND

  • 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.

    PMID: 33535227BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Essam Abdelmonem Sadek, Prof

    Assiut University

    STUDY DIRECTOR

  • Mohamed Hassan Mustafa, Dr

    Assiut University

    STUDY DIRECTOR

  • Abdallah Gamal Abd El Hafeez, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdallah Gamal Abd El Hafeez, Resident

CONTACT

01221248314memo_star440@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

February 1, 2025

Last Updated

January 17, 2024

Record last verified: 2024-01