PeRsOnalising Treatment Of Diabetic Nephropathy:
- Conditions
- Diabetes Mellitus, Type 1Diabetes ComplicationsDiabetic Nephropathies
- Registration Number
- NCT03509454
- Lead Sponsor
- Peter Rossing
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
-
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)
(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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The microvascular function by estimating the glycocalyx thickness 2019 Glycocalyx thickness assessed as perfused boundary region by a hand-hold camera (GlycoCheck)
- Secondary Outcome Measures
Name Time Method Gut microbiome 2019 Characterisation of the gut microbiota and markers of gastrointestinal inflammation
Urine and plasma Flow Cytometry Analysis (FACS) 2019 cell types related to inflammation
Metabolomics in plasma 2019 metabolite risk score in plasma
Metabolomics in urine 2019 metabolite risk score in urine
proteomics in plasma 2019 proteomic risk score in plasma
Autonomic neuropathy 2019 beat to beat variation (R-R test) upon Deep breathing
peripheral neuropathy 2019 vibration perception threshold
proteomics in urine 2019 proteomic risk score in urine
Trial Locations
- Locations (1)
Steno Diabetes Center
🇩🇰Gentofte, Copenhagen, Denmark