About this trial
a prospective, observational, multi-center study with a cohort of 300 patients with Type 2 diabetes and macroalbuminuria. Prospectively we will collect kidney biopsies and analyse the transciptome of the kidney tissue and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. Thereby we hope to be able to discover molecular and clinical profiles, that can help us in the diagnosis of DKD, and to identify different risks of progression that can benefit from different forms of personalized treatment.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Written informed consent
Diagnosis with T2DM according to the American diabetes Association (20)
eGFR >30 mL/min/1.73 m2 (maximum six months old)
Disqualifiers
Signs of acute kidney failure according to the KDIGO classification (21) at the time for kidney biopsy or the last 6 months before kidney biopsy
Hemoglobin < 6 mmol/L
INR >1,4 at the time for biopsy
Platelet count < 100 x 109/l
Trial design
Treatments tested in this trial
- Kidney Biopsy
Treatment groups
Sponsors and collaborators
Herlev Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Hillerod Hospital, Denmark
Collaborator
Zealand University Hospital
Collaborator
Holbaek Sygehus
Collaborator
Slagelse Sygehus
Collaborator
Nykøbing Falster County Hospital
Collaborator
Aarhus University Hospital
Collaborator
The Novo Nordisk Foundation Center for Basic Metabolic Research
Collaborator
Novo Nordisk A/S
Collaborator
Gubra ApS
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Gødstrup Hospital
Collaborator
Steno Diabetes Center Copenhagen
Collaborator
Steno Diabetes Center Sjaelland
Collaborator
Steno Diabetes Center Nordjylland
Collaborator
Michigan Kidney Translational Medical Center
Collaborator