Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT03716401

Prognostic Imaging Biomarkers for Diabetic Kidney Disease

Led by University of Leeds · Updated on 2021-01-11

500

Participants Needed

7

Research Sites

1043 weeks

Total Duration

On this page

Sponsors

U

University of Leeds

Lead Sponsor

U

University of Exeter

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prognostic Imaging Biomarkers for Diabetic Kidney Disease

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Type 2 Diabetes
  • Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73m2 or higher
  • Able to provide informed consent
  • Age between 18 years and 80 years
  • Antidiabetic and antihypertensive medications unchanged for the past 3 months (dose changes allowed)
Not Eligible

You will not qualify if you...

  • History of any transplantation except corneal
  • On permanent dialysis
  • Significant other illnesses with life expectancy less than 1 year
  • Use of investigational drugs within 1 month before screening
  • Known history of urinary obstruction on renal ultrasound (post-void residue over 100 ml or pyelectasis)
  • Known history of aortic endoprosthesis at the kidney level
  • Current pregnancy
  • History of Hepatitis B or C infection
  • Use of antiretroviral medication
  • Known or history of kidney or urinary tract cancer
  • Other known or suspected kidney diseases
  • Cirrhotic or chronic liver disease with ALT more than twice the normal limit
  • Current metastatic cancer or cancer with expected survival less than 4 years
  • Melanoma skin cancer less than 5 years ago (fully resected melanoma over 5 years ago allowed)
  • Any other significant disease or condition that may affect safety or study results
  • Presence of cochlear implants, aneurysm clips, neurological stimulators, implanted cardiac devices, metal heart valves, metal foreign bodies in the eyes, or other metal devices preventing MRI
  • Known allergy to gadolinium contrast
  • Claustrophobia
  • Weight over 250 kg
  • For bariatric arm: contraindications to kidney biopsy, bleeding disorders, severe uncontrolled high blood pressure, or end stage kidney disease with small hyperechoic kidneys

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

Turun Yliopisto

Turku, Finland

Actively Recruiting

2

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

Not Yet Recruiting

3

Università degli Studi di Bari Aldo Moro

Bari, Apulia, Italy

Not Yet Recruiting

4

Lund University Diabetes Centre

Malmö, Sweden, 214 28

Active, Not Recruiting

5

Swiss Institute of Bioinformatics

Lausanne, Switzerland, 1015

Active, Not Recruiting

6

University of Exeter

Exeter, United Kingdom

Not Yet Recruiting

7

University of Leeds

Leeds, United Kingdom

Actively Recruiting

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Research Team

S

Steven Sourbron, PhD

CONTACT

C

Chrysta C Lienczewski, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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