Lactoferrin Supplementation in Diabetic Nephropathy

Summary

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.

Eligibility

Inclusion Criteria:

* Age ≥ 18 years
* Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min/1.73m2) or stage 4 (eGFR 15-29 ml/min/1.73m2)
* Urinary albumin/Creatinine ratio (UACR): moderately and severely increased albuminuria (\> 30 mg/g)
* Stable standard therapy for at least three months prior to inclusion in the study.
* Life expectancy \>12 months.

Exclusion Criteria:

* Participation in other interventional trials
* Current or previous treatment with LF supplements at least three months before inclusion.
* Kidney donor or recipient
* Pregnancy or breastfeeding
* Active malignancy
* Poor adherence potential (e.g. cognitive impairment, psychiatric instability)
* Known intolerance or allergy to lactoferrin

Conditions2

Interventions1

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