NCT03889236已完成不适用
The Effect of Dietary Interventions on Endothelial Glycocalyx Dimensions and Barrier Function in South Asian Patients With Diabetic Nephropathy.
Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年5月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group
研究概览
简要总结
Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in South Asian type 2 diabetic patients with albuminuria.
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)
盲法说明
The placebo and food supplement groups are double blinded.
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
- •South Asian patient with diabetes mellitus type
- •Female or male, aged between 18 and 75 years.
- •Body Mass Index ≥18.
- •CKD-EPI >45 ml/min/1.73m² .
- •Proven microalbuminuria defined as albumin/creatinine ratio ≥0.3 and <30 mg/mmol (single portion) or 3-300 mg albumin per day (24 hours urine collection) in the last twelve months.
- •Systolic blood pressure ≤ 180 mmHg.
- •Treatment with hypoglycemic drugs: metformin, sulphonylureas and/or insulin.
- •Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure.
- •Patients must be able to adhere to the study visit schedule and protocol requirements.
- •If female and of child-bearing age, patients must be non-pregnant, non-breastfeeding, and use adequate contraception.
- •4.3 Exclusion
排除标准
- •Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
- •Non-diabetic renal disease e.g. known polycystic kidney disease.
- •Use of LMW heparin and/or immunosuppressive drugs.
- •Significant food allergies for galactose, nuts, soy, tomato, corn, grape, melon and artichoke, which would make the subject unable to consume the food provided.
- •Signs of active infection or autoimmune disease, requiring systemic treatment.
- •A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
- •Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- •Use of any other investigational drug.
- •Patient has enrolled another clinical trial within last 4 weeks.
结局指标
主要结局
Percentage change from baseline in the Microvascular Health Index in the fasting mimicking diet or food supplement group compared to the placebo group
时间窗: 3 months
次要结局
- Percentage change from baseline in specific urinary heparan sulfate domains in the fasting mimicking diet or food supplement group compared to the placebo(3 months)
- Percentage change from baseline in urinary heparanase levels in the fasting mimicking diet or food supplement group compared to the placebo(3 months)
- Percentage change from baseline in urinary MCP-1 levels in the fasting mimicking diet or food supplement group compared to the placebo(3 months)
- Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) in the fasting mimicking diet or food supplement group compared to the placebo(3 months)
研究者
AnoukvanderVelden
Msc.
Leiden University Medical Center
研究点 (1)
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