Diabetic NephropathiesMR3T - DKDNCT04570735
MRI Biomarkers in Diabetic Kidney Disease
An observational study of Diabetic Nephropathies, run by Poitiers University Hospital at 1 site in France.
Trial summary
Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- MRI
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2020to 26 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with type 2 diabetes with or without diabetic kidney disease and patients with obesity and no diabetes
Who may be able to join
- Common to all 3 category
- Male or female,
- Age≥ 35 years,
- Subject free, with legal protection guardianship or curatorship;
- Enrollment in the French Social Security system;
- Informed consent signed by the patient
Show all 13Show fewer
- Obese patients
- BMI >30 kgm² ;
- With no known diabetes;
- estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m² and urine albumin-creatinin ratio (ACR) < 3 mg/g
- Type 2 diabetic patients without kidney disease
- eGFR > 60 ml/min/1.73m² AND ACR < 3 mg/g,
- Type 2 diabetic patients with diabetic kidney disease defined as eGFR 30 to 60 ml/min/1.73m² OR ACR > 30 mg/mmol.
Who cannot join
- Age < 35 years History of kidney transplant Any contraindication to an MRI examination Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations Pregnant or lactating women, women of childbearing age who do not have effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.
- Conditions
- Diabetic Nephropathies
- Being tested
- MRI
- Keywords
- obesity, diabetic nephropathies, biomarkers, metabolites
- Medical subject headings
- Diabetic Nephropathies, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI
| Study group | Role | What they receive |
|---|---|---|
| patients with type 2 diabetes and diabetic kidney disease | Not described Receives: Diagnostic Test: MRI | |
| patients with type 2 diabetes and no diabetic kidney disease | Not described Receives: Diagnostic Test: MRI | |
| patients with obesity, no diabetes and no kidney disease | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups
Measured: 1 month
Secondary outcomes (2)
Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years
Measured: 3 years
Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start7 Oct 2020
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570735
- Sponsor's protocol ID
- 2019-A02750-57
- Acronym
- MR3T - DKD
- Status last verified
- Dec 2024
- First submitted
- 18 Sep 2020
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Biomarkers in Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT04570735
- Acronym / sponsor ID
- MR3T - DKD / 2019-A02750-57
- Conditions
- Diabetic Nephropathies
- Keywords
- obesity, diabetic nephropathies, biomarkers, metabolites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with type 2 diabetes and diabetic kidney disease | – | Diagnostic Test: MRI |
| patients with type 2 diabetes and no diabetic kidney disease | – | Diagnostic Test: MRI |
| patients with obesity, no diabetes and no kidney disease | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes with or without diabetic kidney disease and patients with obesity and no diabetes
Key inclusion criteria (13 listed)
- Common to all 3 category
- Male or female,
- Age≥ 35 years,
- Subject free, with legal protection guardianship or curatorship;
- Enrollment in the French Social Security system;
Key exclusion criteria (1 listed)
- Age < 35 years History of kidney transplant Any contraindication to an MRI examination Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations Pregnant or lactating women, women of childbearing age who do not have effective contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI | Diagnostic test | patients with obesity, no diabetes and no kidney disease, patients with type 2 diabetes and diabetic kidney disease, patients with type 2 diabetes and no diabetic kidney disease |
Primary outcome
Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups
Time frame: 1 month
2 secondary outcomes
Association between MRS biomarkers and annual glomerural filtration rate slope calculated within 3 previous years
Time frame: 3 years
Correlation between metabolic MRS biomarkers and urine and plasma metabolites quantification.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between morphometric and functional and metabolic biomarker data obtained by magnetic resonance spectroscopy (MRS) in 3 different patient groups (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.