Diabetic Nephropathy
Conditions
Keywords
lactoferrin, diabetic nephropathy
Brief 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.
Interventions
DIETARY_SUPPLEMENTLactoferrin
Lactoferrin 250mg/day
DRUGAntidiabetic
Antidiabetic (insulin+/oral hypoglycemics)
OTHERPlacebo
Placebo pills
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary albumin/creatinine ratio | Baseline and after 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kidney function tests (serum creatinine, estimated glomerular filteration rate ( by ckd-epi equation) and blood urea nitrogen). | Baseline and after 12 weeks | — |
| Glycemic indices (fasting blood glucose and hemoglobin A1c). | Baseline and after 12 weeks | — |
| Lipid profile (low-density lipoprotein cholesterol, high- density lipoprotein cholesterol, total cholesterol and triglycerides). | Baseline and after 12 weeks | — |
| Body mass index | Baseline and after 12 weeks | Weight and height will be combined to report BMI in kg/m\^2 |
| Osteopontin as a biomarker of oxidative stress | Baseline and after 12 weeks | — |
| Quality of life using the Kidney Disease Quality of Life Instrument (KDQOL -36™ Survey) | Baseline and after 12 weeks | — |
Countries
Egypt
Contacts
CONTACTNihal Halawa, MSc in Clinical Pharmacy
Outcome results
None listed