Trials / Recruiting
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Herlev Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- —
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.
Detailed description
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.
Conditions
- Chronic Kidney Diseases
- Albuminuria
- Diabetic Kidney Disease
- Diabetic Nephropathies
- Diabetes type2
- Molecular Sequence Variation
- Kidney Biopsy
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Kidney Biopsy | Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis |
Timeline
- Start date
- 2021-08-10
- Primary completion
- 2043-12-31
- Completion
- 2043-12-31
- First posted
- 2021-06-07
- Last updated
- 2025-12-24
Locations
13 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04916132. Inclusion in this directory is not an endorsement.