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.
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)
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
People with type 2 diabetes, albuminuria and eGFR \> 30 who are willing to undergo a kidney biopsy
Cohort
Prospective
Kidney Biopsy
Procedure/SurgeryHarvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis
Prevalence
To investigate the prevalence of biopsy-proven diabetic nephropathy in individuals with T2DM with severe albuminuria; urine albumin/creatinine ratio (UACR) \>700 mg/g.
Improved clinical diagnosis
To investigate whether clinical variables, transcriptomic, proteomic and/or metabolomic profiles as well as genetic variation can predict the presence of diabetic nephropathy in a kidney biopsy.
diabetic retinopathy
To describe the sensitivity and specificity of diabetic retinopathy in predicting biopsy-proven diabetic nephropathy
Kidney Biopsy
describe the prognostic value of different histological and molecular findings on kidney biopsy in individuals with biopsy-proven diabetic nephropathy
non-diabetic nephropathy vs. biopsy-proven diabetic nephropathy
describe the prognostic value of different histological and molecular findings on the kidney biopsy in individuals with non-diabetic nephropathy compared to biopsy-proven diabetic nephropathy.
Click on the lead sponsor to view all of their trials.
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
