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Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease

RECRUITINGPhase 2Sponsored by Mostafa Bahaa
Actively Recruiting
PhasePhase 2
SponsorMostafa Bahaa
Started2022-12-20
Est. completion2025-12-20
Eligibility
Age40 Years – 65 Years
Healthy vol.Accepted

Summary

The prevalence of diabetes mellitus is increasing worldwide, and its complications are one of the leading causes of mortality from non-communicable diseases. Due to the high prevalence of diabetes and because 30-40% of diabetic patients \[both type 1 (T1DM) and type 2 (T2DM) diabetes mellitus\] develop kidney dysfunction, diabetic nephropathy (DN) is the main cause of end-stage renal disease worldwide. The renin-angiotensin-aldosterone system (RAAS), endothelin, and urotensin II are vasoactive hormones that have been extensively studied as other mediators although their relation to diabetic nephropathy is still speculative.

Eligibility

Age: 40 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria:

* Age between 40 and 65.
* Both genders will be included.
* Type II diabetes mellitus confirmed by Glycosylated Hemoglobin A₁C.
* Diagnosis of diabetic nephropathy, which will be defined as persistent albuminuria with urinary albumin creatinine ratio (UACR) range \[30-300 mg /gm\], confirmed on at least two occasions 3-6 months apart, with or without decline in glomerular filtration rate at screening and receiving angiotensin receptor blockers (ARBs) and sodium-glucose cotransporter 2 (SGLT2) inhibitors therapy.
* Hemoglobin A₁C ranges from 6.5% to 10% with regular use of insulin and or/oral hypoglycemic drugs.

Exclusion Criteria:

* Other types of diabetes mellitus
* Uncontrolled hypertension (Blood pressure ≥ 180/110).
* Urinary tract infection.
* Severe anemia (Hemoglobin ˂10).
* Critically ill patient.
* Past operation, past history of trauma, heavy exercise.
* Severe renal failure (e GFR ˂ 30ml/min/1.73 m2).
* Systemic inflammatory and autoimmune diseases.
* Malignancy.
* Pregnancy and lactating women.
* Other causes of chronic kidney disease.

Conditions2

DiabetesDiabetic Nephropathies

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