Fib to Alb Ratio in Type 2 Dkd

Not yet recruiting

• Conditions: CKD; Type 2 Diabetes

• Registration Number: NCT05691985
• Lead Sponsor: Assiut University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Status Verified: 2024-01
• Study Start: 2024-01
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-03
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The association of fibrinogen to albumin ratio (FAR) with DKD type 2.	baseline	investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2.