NCT01671969已完成不适用
Very Low Calorie Diet for Diabetic Kidney Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Urinary albumin excretion
研究概览
简要总结
The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Type 2 Diabetes
- •Age > 18
- •Body mass index ≥ 30
- •Presumed or biopsy-proven diabetic nephropathy
- •Estimated GFR < 40 ml/min/1.73 meters squared
- •Proteinuria > 0.5 gm/day
- •Motivated to lose weight
- •Stable medical co-morbidities
- •Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated)
排除标准
- •Inability to sign informed consent
- •Life expectancy of < 1 year
- •Expected need for initiation of dialysis within 9 months
- •Type 1 Diabetes
- •Recent myocardial infarction or stroke (past 3 months)
- •Unstable angina
- •Active cancer
- •Pregnancy/lactation
- •Serious psychiatric diseases
- •Substance abuse
- •Uncontrolled hypertension (> 180/110)
- •Ineligible for VLCD based on laboratory data
结局指标
主要结局
Urinary albumin excretion
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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