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PeRsOnalising Treatment Of Diabetic Nephropathy: (PROTON)

2018年4月16日 更新者:Peter Rossing

PeRsOnalising Treatment Of Diabetic Nephropathy: From Albuminuria to Multidimensional Characterisation of Diabetic Nephropathy - a Cross-sectional Study

Background: Today diabetic nephropathy is a frequent, and the most lethal and costly complication of diabetes. Although treating blood pressure with agents blocking renin angiotensin system has improved outcome, the prognosis is still poor and no new interventions have been successful during the past decade. There is an urgent need for discovery of new pathways behind the development and progression of diabetic nephropathy as well as of biomarkers which can identify subjects at risk of developing adverse events. Objective: By using a multidimensional 'omics' approach, we aim to search for novel proteins, metabolites and pathways that will point to the putative new mechanisms which underlie the early renal decline.

Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.

研究概览

详细说明

Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.

研究类型

观察性的

注册 (实际的)

210

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Copenhagen
      • Gentofte、Copenhagen、丹麦、2820
        • Steno Diabetes center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

160 patients with type 1 diabetes and different stages of diabetic nephropathy (50 with normoalbuminuria; 50 with microalbuminuria; and 60 with macroalbuminuria -including at least 30 with concurrent estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2) compared to 50 healthy non-diabetic controls.

描述

Inclusion Criteria:

  • Patients with type 1 diabetes
  • Written informed consent must be provided before participation
  • Male or female patients >18 years of age with a diagnosis of type 1 diabetes (WHO criteria)
  • Persistent urinary albumin creatinine ratio (UACR) assessed from EPJ (Electronic Patient Journal):
  • < 30 mg/g in 2 out of 3 consecutive samples (normoalbuminuria)
  • 30 - 299 mg/g in 2 out of 3 consecutive samples (microalbuminuria)
  • ≥ 300 mg/g in 2 out of 3 consecutive samples (macroalbuminuria) - at least 30 with concurrent eGFR < 60 ml/min/1.73m2

    2. Control subjects without diabetes

  • Written informed consent must be provided before participation.
  • Male or female patients >18 years of age without a diagnosis of diabetes (assessed by Hb1Ac, haemoglobin and creatinine)

Exclusion Criteria: (Both subjects with and without diabetes)

  • Non-diabetic kidney disease as indicated by medical history and/or laboratory findings
  • Renal failure (eGFR<15 ml/min/1.73m2), dialysis or kidney transplantation
  • Change in RAAS blocking treatment during the last month
  • Treatment with antibiotics during the last 2 month
  • Pregnancy or breastfeeding (urine HCG is performed on all fertile women)
  • Patients who, in the judgement of the investigator, is incapable to participate
  • For controls: Other diseases or intake of medicine which in the judgement of the investigator could affect the results, specifically renal, cardiovascular or inflammatory/infectious diseases should be considered for exclusion

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Type 1 DM, Normo albuminuric
Type 1 diabetics with no history of albumnuria (UACR < 30 mg/g in 2 out of 3 consecutive samples)
Type 1 DM, Micro albuminuric
Type 1 diabetics with history of micro albumnuria (UACR 30-299 mg/g in 2 out of 3 consecutive samples)
Type 1 DM, Macro albuminuric
Type 1 diabetics with history of macro albumnuria (UACR 30-299 mg/g in 2 out of 3 consecutive samples)
Healthy subjects
Subjects with no history of diabetes, other diseases or intake of medicine which in the judgement of the investigator could affect the results, specifically renal, cardiovascular or inflammatory/infectious diseases should be considered for exclusion.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The microvascular function by estimating the glycocalyx thickness
大体时间:2019
Glycocalyx thickness assessed as perfused boundary region by a hand-hold camera (GlycoCheck)
2019

次要结果测量

结果测量
措施说明
大体时间
Gut microbiome
大体时间:2019
Characterisation of the gut microbiota and markers of gastrointestinal inflammation
2019
Urine and plasma Flow Cytometry Analysis (FACS)
大体时间:2019
cell types related to inflammation
2019
Metabolomics in plasma
大体时间:2019
metabolite risk score in plasma
2019
Metabolomics in urine
大体时间:2019
metabolite risk score in urine
2019
proteomics in urine
大体时间:2019
proteomic risk score in urine
2019
proteomics in plasma
大体时间:2019
proteomic risk score in plasma
2019
Autonomic neuropathy
大体时间:2019
beat to beat variation (R-R test) upon Deep breathing
2019
peripheral neuropathy
大体时间:2019
vibration perception threshold
2019

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 学习椅:peter Rossing、Steno Diabetes Center Copenhagen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年4月1日

初级完成 (实际的)

2017年10月1日

研究完成 (实际的)

2018年4月1日

研究注册日期

首次提交

2018年4月10日

首先提交符合 QC 标准的

2018年4月16日

首次发布 (实际的)

2018年4月26日

研究记录更新

最后更新发布 (实际的)

2018年4月26日

上次提交的符合 QC 标准的更新

2018年4月16日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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