Diabetic Nephropathies
Conditions
Brief 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.
Interventions
DRUGValsartan 80 mg
Valsartan is an angiotensin receptor blocker.
DRUGEmpagliflozin 10 MG
Empagliflozin is an oral hypoglycemic drug.
DRUGLevocetirizine
Levocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions
Sponsors
Mostafa Bahaa
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of albuminuria | 3 months | Reduction of albuminuria in diabetic nephropathy |
Countries
Egypt
Outcome results
None listed