The Effect of Lactoferrin on the Clinical Outcome of Patients With Diabetic Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urinary albumin/creatinine ratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Lactoferrin arm
30 patients will receive standard therapy + LF in an oral dose of 250 mg/day for 12 weeks
干预措施: Antidiabetic (Drug)
Placebo arm
30 patients receiving standard therapy + placebo for 12 weeks.
干预措施: Antidiabetic (Drug)
Placebo arm
30 patients receiving standard therapy + placebo for 12 weeks.
干预措施: Placebo (Other)
Lactoferrin arm
30 patients will receive standard therapy + LF in an oral dose of 250 mg/day for 12 weeks
干预措施: Lactoferrin (Dietary Supplement)
结局指标
主要结局
Urinary albumin/creatinine ratio
时间窗: Baseline and after 12 weeks
次要结局
- 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)
- 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)
研究者
Nihal Mohamed Halawa
Assistant lecturer of clinical pharmacy
Ain Shams University