PeRsOnalising Treatment Of Diabetic Nephropathy: From Albuminuria to Multidimensional Characterisation of Diabetic Nephropathy - a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The microvascular function by estimating the glycocalyx thickness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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)
排除标准
- •(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
结局指标
主要结局
The microvascular function by estimating the glycocalyx thickness
时间窗: 2019
Glycocalyx thickness assessed as perfused boundary region by a hand-hold camera (GlycoCheck)
次要结局
- proteomics in urine(2019)
- Gut microbiome(2019)
- Urine and plasma Flow Cytometry Analysis (FACS)(2019)
- Metabolomics in plasma(2019)
- Metabolomics in urine(2019)
- proteomics in plasma(2019)
- Autonomic neuropathy(2019)
- peripheral neuropathy(2019)
研究者
Peter Rossing
Professor, MD, DMsc
Steno Diabetes Center Copenhagen