Multiple pathways and mediators, including oxidative stress, inflammation, and the over-activity of the renin-angiotensin-aldosterone system are involved in the development of albuminuria and progression of diabetic nephropathy (DN), of which oxidative stress is the most prominent. Previous research has shown that lactoferrin (LF) has multi-pharmacological properties, including antioxidant, anti-inflammatory, antiviral, anticancer, antibacterial, antifibrotic and immunogenic properties . Lactoferrin was reported to be a useful nutritional supplement to support immunity and antioxidant status and suppress systemic inflammatory and oxidative stress biomarkers ( ↓ TNF-α, ↓ IL-6, ↓ IFN-γ, ↓ IL-1β, ↑ IL-10) in previous studies. Lactoferrin, in vitro, has been reported to reduce oxidative stress, inflammation, apoptosis and fibrosis in acute and chronic kidney disease. Moreover, different rat models with kidney injury have proven the nephroprotective effect of LF through decreasing the levels of urinary albumin to creatinine ratio, serum creatinine, serum urea, and blood urea nitrogen (BUN) and also through reducing the expression of kidney damage markers; osteopontin, renin and IL-6. Furthermore, LF improved glycemic control and lipid markers through significant improvement of HbA1c, FBG, insulin resistance, body mass index and lipid markers. Hence, this study aims to evaluate the effect of LF on the clinical outcomes of type 2 diabetic patients with DN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Lactoferrin 250mg/day
Antidiabetic (insulin+/oral hypoglycemics)
Placebo pills
Ain Shams University Hospitals
Cairo, Egypt
RECRUITINGUrinary albumin/creatinine ratio
Time frame: Baseline and after 12 weeks
Kidney function tests (serum creatinine, estimated glomerular filteration rate ( by ckd-epi equation) and blood urea nitrogen).
Time frame: Baseline and after 12 weeks
Glycemic indices (fasting blood glucose and hemoglobin A1c).
Time frame: Baseline and after 12 weeks
Lipid profile (low-density lipoprotein cholesterol, high- density lipoprotein cholesterol, total cholesterol and triglycerides).
Time frame: Baseline and after 12 weeks
Body mass index
Weight and height will be combined to report BMI in kg/m\^2
Time frame: Baseline and after 12 weeks
Osteopontin as a biomarker of oxidative stress
Time frame: Baseline and after 12 weeks
Quality of life using the Kidney Disease Quality of Life Instrument (KDQOL -36™ Survey)
Time frame: Baseline and after 12 weeks
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