Prognostic Imaging Biomarkers for Diabetic Kidney Disease

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
SUMMARY

Diabetic kidney disease (DKD) is a common complication of diabetes, and is now the most common form of chronic kidney disease. DKD is the leading cause of kidney disease requiring dialysis or kidney transplantation, and its global incidence and prevalence have reached epidemic levels. While the risk of developing DKD can be ameliorated by tight blood glucose and blood pressure control, it is not fully preventable and once established DKD cannot be cured. Therefore many patients are left with poor and worsening health and with increased mortality risk. Developing new ways to treat DKD requires healthcare professionals to be able to identify those patients most in need of treatment. One promising approach for identifying patients that are at risk is the use of imaging measurements (called biomarkers) derived from Magnetic Resonance Imaging (MRI) and Ultrasound (US) of the kidneys. Evidence from early studies shows that such imaging biomarkers can identify underlying problems in DKD such as blood supply, oxygen supply, kidney scarring and kidney function, in ways that are better than those currently available. The investigators think that imaging biomarkers will improve the identification of patients who are likely to decline from DKD in the short term. The changes found by imaging may even happen before effects on the blood and urine. The investigators plan to test this hypothesis by performing a study observing 500 patients with early stage DKD, recruited in 5 sites across Europe. All patients will have detailed assessment at the start of their involvement, including clinical assessment, blood and urine samples, and MRI and US scans. The investigators will look at whether imaging biomarkers are associated with other measures that predict progression in DKD, and follow patients every year for 3 years (4 years total study participation) to see if the imaging biomarkers predict worsening DKD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosis Diabetes Type 2;

• eGFR \>= 30 ml/min/1.73m2;

• Able to provide informed consent;

• Age between 18 years and 80 years;

• Unchanged antidiabetic and antihypertensive medication for the past 3 months (not including dose changes).

Locations
Other Locations
Finland
Turun Yliopisto
RECRUITING
Turku
France
Centre Hospitalier Universitaire de Bordeaux
NOT_YET_RECRUITING
Bordeaux
Italy
Università degli Studi di Bari Aldo Moro
NOT_YET_RECRUITING
Bari
Sweden
Lund University Diabetes Centre
ACTIVE_NOT_RECRUITING
Malmo
Switzerland
Swiss Institute of Bioinformatics
ACTIVE_NOT_RECRUITING
Lausanne
United Kingdom
University of Exeter
NOT_YET_RECRUITING
Exeter
University of Leeds
RECRUITING
Leeds
Contact Information
Primary
Steven Sourbron, PhD
s.sourbron@leeds.ac.uk
0044-113-34-38003
Backup
Chrysta C Lienczewski, BS
boridley@umich.edu
734-615-5021
Time Frame
Start Date: 2018-09-01
Estimated Completion Date: 2038-09-01
Participants
Target number of participants: 500
Treatments
Bari: Biopsy Arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples.~Additionally, participants at the Bari site will have an additional renal biopsy at baseline.
Bordeaux: MRI Follow-up arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples.~Additionally, participants at the Bordeaux site will have an additional ultrasound US and MRI in Follow-up year 2.
Exeter: Microvascular arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples.~Participants at the Exeter site will undergo microvascular measurements including estimating glycocalyx thickness at baseline and at 2 years follow-up.
Leeds: Microstructure MRI arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection.~Participants at the Leeds' site will have an extended MRI scan at baseline including novel microstructure MRI measurements.
Turku: PET arm
All study participants will undergo a baseline MRI and US and corresponding blood and urine sample collection. This will be followed up annually for additional blood and urine samples.~Additionally, participants at the Turku site will undergo a renal Positron Emission Tomography (PET) scan at the baseline timepoint.
Sponsors
Collaborators: Swiss Institute of Bioinformatics, University of Turku, University of Bari, University of Exeter, University Hospital, Bordeaux, Lund University
Leads: University of Leeds

This content was sourced from clinicaltrials.gov