Biopsy-proven Diabetic Nephropathy in People With Type 2 Diabetes. Prevalence and Predictive Factors

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
View:

• 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)

• urine-albumin/creatinine-ratio (uACR) \> 700 mg/g or 24 hours urine albumin \>700 mg on more than one measurement

Locations
Other Locations
Denmark
Aalborg universitetshospital
RECRUITING
Aalborg
Rigshospitalet
RECRUITING
Copenhagen
Steno Diabetes Center Copenhagen
RECRUITING
Copenhagen
Regionshospitalet Gødstrup
RECRUITING
Gødstrup
Herlev Hospital
RECRUITING
Herlev
Kristine D Schandorff
RECRUITING
Hillerød
Holbæk Hospital
RECRUITING
Holbæk
Sjællands Universitetshospital, Køge
RECRUITING
Køge
Nykøbing Falster Sygehus
RECRUITING
Nykøbing Falster
Odense universitetshospital
RECRUITING
Odense
Sjællands Universitetshospital, Roskilde
RECRUITING
Roskilde
Aarhus Universitetshospital, Skejby
RECRUITING
Skejby
Slagelse Sygehus
RECRUITING
Slagelse
Contact Information
Primary
Marie Møller
marie.moeller@regionh.dk
+4561695364
Backup
Ditte Hansen
ditte.hansen.04@regionh.dk
+4538682056
Time Frame
Start Date: 2021-08-10
Estimated Completion Date: 2043-12-31
Participants
Target number of participants: 300
Treatments
Peolpe with T2DM and albuminuria
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.
Sponsors
Collaborators: The Novo Nordisk Foundation Center for Basic Metabolic Research, Zealand University Hospital, Steno Diabetes Center Copenhagen, Odense University Hospital, Slagelse Sygehus, Michigan Kidney Translational Medical Center, Aarhus University Hospital, Nykøbing Falster County Hospital, Steno Diabetes Center Nordjylland, Gubra ApS, Gødstrup Hospital, Hillerod Hospital, Denmark, Novo Nordisk A/S, Aalborg University Hospital, Steno Diabetes Center Sjaelland, Holbaek Sygehus, Rigshospitalet, Denmark
Leads: Herlev Hospital

This content was sourced from clinicaltrials.gov