Clinical trial NCT05691985: Fib to Alb Ratio in Type 2 Dkd
Official title: Fibrinogen to Albumin Ratio (FAR) as a Risk Factor for Type 2 Diabetic Nephropathy(DN)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CKD
Type 2 Diabetes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The association of fibrinogen to albumin ratio (FAR) with DKD type 2.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Essam Abdelmonem Sadek, Prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed Hassan Mustafa, Dr
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Abdallah Gamal Abd El Hafeez, Resident
role: PRINCIPAL_INVESTIGATOR
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