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临床试验/NCT02384902
NCT02384902已完成不适用

Effect of Dietary Glycemic Index/Load on Kidney-related Biomarkers and Inflammation in Diabetic Nephropathy Patients

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.

研究概览

简要总结

low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet.

low GL may have more favorable effect than low GI diet.

详细描述

According to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed for all volunteers. Dietary records forms were given to all subjects and they were educated how to record their dietary intakes. The investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diabetic nephropathy, medication stable

排除标准

  • •poor adherence of dietary recommendations, any changes in kind or dosage of medications

研究组 & 干预措施

low GI

Experimental

low GI: participants were asked to consume low GI foods (GI<55) in abundant, medium GI in moderate and high GI (GI>70) rarely.

干预措施: low GI (Other)

low GL

Experimental

low GL: participants were asked to consume low GI foods and the amount of carbohydrate was controlled.

干预措施: low GI (Other)

conventional diet

Experimental

conventional diet: all carbohydrate were treated as the same.

干预措施: conventional diet (Other)

结局指标

主要结局

Serum creatinine (and blood urea nitrogen (BUN) (mg/dL) were measured by colorimetric method and enzymatic colorimetric method using commercial assay kit.

时间窗: baseline, wk 12

次要结局

  • Serum levels of high sensitive C- reactive protein (hs-CRP) (mg/L) were quantified by using an ultrasensitive latex-enhanced immunoturbidimetric assay (Randox Laboratory Ltd., Belfast, United Kingdom).(baseline, wk 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leila Azadbakht

Leila Azadbakht

Isfahan University of Medical Sciences

研究点 (1)

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