Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum creatinine
研究概览
简要总结
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
详细描述
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18 years old
- •diabetic nephropathy
- •Fasting Blood Sugar more than 126 milligram per deciliter
- •Proteinuria 30-300 milligram per deciliter (microalbuminuria)
- •Glomerular Filtration Rate more than 90 milliliter per minute
- •Not having hyperthyroidism or hypothyroidism
- •Not having any feverish urinary tract infection
- •Not using any kind of drug including Cigarette
- •Not having any liver disease
- •Not having any cancer and inflammatory diseases
- •Not having more than 4 kilogram weight loss during last 3 months
- •Not using any magnesium-rich supplement
排除标准
- •changing medicine dose
- •Not having adherence (using less than 75 percent of medicines)
- •Cardiac Arrhythmias
研究组 & 干预措施
Placebo
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day
Magnesium Oxide
magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet
干预措施: Magnesium Oxide (Dietary Supplement)
结局指标
主要结局
Serum creatinine
时间窗: 12 weeks
次要结局
- Serum insulin level(12 weeks)
- Low Density Lipoprotein(12 weeks)
- Very Low Density Lipoprotein(12 weeks)
- Hemoglobin A1c(12 weeks)
- Proteinuria(12 weeks)
- High Density Lipoprotein(12 weeks)
- Blood Urine Nitrogen(12 weeks)
- Glomerular Filtration Rate(12 weeks)
- Fasting Blood Sugar(12 weeks)
- Triglyceride(12 weeks)
- Total Cholesterol(12 weeks)
- high sensitive C-Reactive Protein(12 week)
研究者
Leila Azadbakht
Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy
Isfahan University of Medical Sciences