RecruitingNCT04916132

Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

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


Sponsor

Herlev Hospital

Enrollment

300 participants

Start Date

Aug 10, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating diabetic kidney disease in people with type 2 diabetes by performing kidney biopsies to better understand why some people develop severe kidney damage and identify factors that predict who is most at risk. **You may be eligible if:** - You are 18 or older with type 2 diabetes - Your kidneys are filtering at a reasonable rate (eGFR above 30) - You have high levels of protein in your urine (a sign of significant kidney damage) - You can give written consent **You may NOT be eligible if:** - You have recently experienced acute kidney failure - You have conditions that make a kidney biopsy unsafe (such as uncontrolled high blood pressure, severe anemia, bleeding risk, or only one functioning kidney) - You have had a previous kidney biopsy or kidney transplant - You are pregnant or planning to become pregnant before the biopsy - You take the blood thinner Marcoumar (phenprocoumon) and cannot safely stop it - You have a very high risk of dangerous blood clots if anticoagulation is paused Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREKidney Biopsy

Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis


Locations(13)

Aarhus Universitetshospital, Skejby

Skejby, Aarhus, Denmark

Steno Diabetes Center Copenhagen

Copenhagen, Gentofte, Denmark

Kristine D Schandorff

Hillerød, Hillerød, Denmark

Holbæk Hospital

Holbæk, Holbæk, Denmark

Rigshospitalet

Copenhagen, København Ø, Denmark

Sjællands Universitetshospital, Køge

Køge, Køge, Denmark

Nykøbing Falster Sygehus

Nykøbing Falster, Nykøbing F, Denmark

Sjællands Universitetshospital, Roskilde

Roskilde, Roskilde, Denmark

Slagelse Sygehus

Slagelse, Slagelse, Denmark

Aalborg universitetshospital

Aalborg, Denmark

Regionshospitalet Gødstrup

Gødstrup, Denmark

Herlev Hospital

Herlev, Denmark

Odense universitetshospital

Odense, Denmark

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NCT04916132


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