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临床试验/NCT00484068
NCT00484068已完成不适用

Effect of Chicken-Based Diet Versus Enalapril on Albuminuria in Patients With Type 2 Diabetes and Microalbuminuria: a One-Year Randomized Controlled Study

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2003年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
urinary albumin excretion

研究概览

简要总结

Diabetic nephropathy (DN) is a chronic diabetic complication and affects up to 40% of patients. The first line treatment for DN is angiotensin blockers drugs that are used to reduce the protein concentration in urine.Previous data showed that this protein, namely albuminuria, could also be reduced in a short term-period by the replacement of red meat in the diet with chicken. The aim of this study is to compare the effects of this chicken diet with enalapril on albuminuria in a long-term period( 12 months)in type 2 diabetic patients.

详细描述

Replacement of red meat in the diet with chicken reduces urinary albumin excretion rate (UAER) and improves lipid profile in type 2 diabetic patients with micro- and macroalbuminuria in short term studies. The aim of this study was to compare the long-term effect of a chicken-based diet (CD) versus enalapril treatment on renal function and lipid profile in microalbuminuric type 2 diabetic patients. In this 12-month controlled clinical trial 28 patients were randomized to an experimental diet (CD plus active placebo) or enalapril treatment (enalapril 10 mg/day plus patient's usual diet). UAER (immunoturbidimetry), blood pressure levels, anthropometric indices, and compliance with the diet were evaluated monthly. Glomerular filtration rate (51Cr-EDTA), lipid, glycemic, and nutritional indices were measured at baseline, and quarterly. UAER was reduced after CD [n=13; 62.8 (38.4-125.1) to 49.1 (6.2-146.5) mcg/min; P<0.001] and after enalapril treatment [n=15; 55.8 (22.6-194.3) to 23.1 (4.0-104.9) mcg/min; P<0.001]. The reduction of UAER was already significant at 4th month, and there was no difference between the UAER reduction after CD [32% (95% CI: 6.7-57.6) and after enalapril treatment [44.7% (95% CI: 28.3-61.1); P=0.366]. In conclusion, CD and the ACE inhibitor enalapril promoted similar UAER reduction in patients with type 2 diabetes and microalbuminuria. A chicken-based diet might represent an additional therapeutic approach to management of diabetic nephropathy.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with type 2 diabetes mellitus (according to World Health Organization criteria) attending the Endocrine Division's outpatient clinic at Hospital de Clínicas de Porto Alegre, Brazil. Patients were selected according to the following criteria: age <75 years, A1c <10%, 24-hour UAER 20 mcg/min and 199 mcg/min confirmed at least twice in a 6-month period, serum triglycerides <400 mg/dl and normal liver and thyroid function tests.

排除标准

  • Patients were excluded from the study if they had BMI >34 kg/m2, serum creatinine >1.5 mg/dl, repeated episodes of urinary tract infection, other renal diseases, symptomatic autonomic neuropathy, heart failure, and acute myocardial infarction, coronary artery revascularization procedures or stroke within the last 6 months.

结局指标

主要结局

urinary albumin excretion

时间窗: during study

serum lipids

时间窗: during study

nutritional status

时间窗: during study

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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Chicken-Diet vs. Enalapril to Reduce Albuminuria | 临床试验