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.
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.
Study Type
OBSERVATIONAL
Enrollment
210
Steno Diabetes Center
Gentofte Municipality, Copenhagen, Denmark
The microvascular function by estimating the glycocalyx thickness
Glycocalyx thickness assessed as perfused boundary region by a hand-hold camera (GlycoCheck)
Time frame: 2019
Gut microbiome
Characterisation of the gut microbiota and markers of gastrointestinal inflammation
Time frame: 2019
Urine and plasma Flow Cytometry Analysis (FACS)
cell types related to inflammation
Time frame: 2019
Metabolomics in plasma
metabolite risk score in plasma
Time frame: 2019
Metabolomics in urine
metabolite risk score in urine
Time frame: 2019
proteomics in urine
proteomic risk score in urine
Time frame: 2019
proteomics in plasma
proteomic risk score in plasma
Time frame: 2019
Autonomic neuropathy
beat to beat variation (R-R test) upon Deep breathing
Time frame: 2019
peripheral neuropathy
vibration perception threshold
Time frame: 2019
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