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.
The PRIMETIME project is made to bring together molecular, translational and clinical scientists to create collaborations and build a scientific bridge between diabetology, nephrology, clinical biochemistry, and pathology. The ultimately goal is to bring forward an improved understanding of the most frequent cause of end stage renal disease: DKD. We aim to improve the diagnostic accuracy as well as the treatment precision by investigating in detail the features of histology and protein expression in both retrospective(WP1) and prospective(WP2) kidney biopsy material. PRIMETIME WP2 is a prospective, observational, multi-center study with a cohort of 300 patients. We plan to create a systematically unselected cohort of patients with Type2 diabetes and macroalbuminuria as a sign of kidney injury. Prospectively we will collect research kidney biopsies and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. The biopsies will be thoroughly investigated with cutting-edge molecular technologies and associated to the biomarkers, disease course and clinical outcome. The participants will afterward be followed in 20 years.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.
Study Type
OBSERVATIONAL
Enrollment
300
Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis
Aarhus Universitetshospital, Skejby
Skejby, Aarhus, Denmark
RECRUITINGSteno Diabetes Center Copenhagen
Copenhagen, Gentofte, Denmark
RECRUITINGKristine D Schandorff
Hillerød, Hillerød, Denmark
RECRUITINGHolbæk Hospital
Holbæk, Holbæk, Denmark
RECRUITINGRigshospitalet
Copenhagen, København Ø, Denmark
RECRUITINGSjællands Universitetshospital, Køge
Køge, Køge, Denmark
RECRUITINGNykøbing Falster Sygehus
Nykøbing Falster, Nykøbing F, Denmark
RECRUITINGSjællands Universitetshospital, Roskilde
Roskilde, Roskilde, Denmark
RECRUITINGSlagelse Sygehus
Slagelse, Slagelse, Denmark
RECRUITINGAalborg universitetshospital
Aalborg, Denmark
RECRUITING...and 3 more locations
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.
Time frame: From baseline to end inclusion (3 years)
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.
Time frame: From baseline to end inclusion (3 years)
diabetic retinopathy
To describe the sensitivity and specificity of diabetic retinopathy in predicting biopsy-proven diabetic nephropathy
Time frame: From baseline to end inclusion (3 years)
Kidney Biopsy
describe the prognostic value of different histological and molecular findings on kidney biopsy in individuals with biopsy-proven diabetic nephropathy
Time frame: From baseline to end of followup (20 years)
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.
Time frame: From baseline to end of followup (20 years)
proteomic and metabolomic
describe the prognostic value of the proteomic and metabolomic profiles in biopsy-proven diabetic nephropathy.
Time frame: From baseline to end of followup (20 years)
genetic variants
describe the prognostic value of different forms of genetic variation in biopsy-proven diabetic nephropathy
Time frame: From baseline to end of followup (20 years)
Microbiome
describe the prognostic value of different compositions of the microbiome and its relation to biopsy and clinical findings
Time frame: From baseline to end of followup (20 years)
Annual changes in kidney status
Annual changes in kidney status (defined by yes/no: initiation of dialysis, kidney transplantation, renal death or decrease in eGFR \> 40 % compared to eGFR at baseline)
Time frame: From baseline to end of followup (20 years)
Annual decline in eGRF
Annual decline in eGRF
Time frame: From baseline to end of followup (20 years)
Annual changes in albuminuria.
Annual changes in albuminuria.
Time frame: From baseline to end of followup (20 years)
Annual events of cardiovascular disease
Events of cardiovascular disease (fatal CV events, non-fatal stroke, non-fatal myocardial infarction, hospitalization for heart failure, PCI or bypass surgery (heart or legs), amputations due to ischemia, and unstable angina)
Time frame: From baseline to end of followup (20 years)
Death
Death (any cause).
Time frame: From baseline to end of followup (20 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.