Type 1 Diabetes Mellitus With Diabetic NephropathypeeDIAB2NCT02164279
Validation of Biomarkers of Diabetic Nephropathy in Type I Diabetic Children
An observational study of Type 1 Diabetes Mellitus With Diabetic Nephropathy, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
About 30 to 40% of patients suffering from type I diabetes are at risk of developing a diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease. Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset of DN. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Diabetic Nephropathy
- What is being tested?
- Urinary sample collection
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2013to 25 May 2016
- 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 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients are selected in a cohort of 317 type I diabetic children constituting a urine samples collection. Indeed, urine sample of 317 patients have been collected between 2004 and 2008. These patients will be called to obtain the participation of 180 children in this study.
Who may be able to join
- Patient with a type I diabetes diagnosed before 15 years-old
- Urinary collection done 5 years after the diagnosis
- Urinary collection done without any acute intermittent pathology
- Urinary collection done without any treatment (other than diabetes treatment)
- Glomerular filtration rate ≥ 60 mL/min at the moment of the urinary collection already done
- Informed consent obtained aposteriori for the analysis of the urinary samples collected between 2004 and 2008, and consent obtained for the analysis of urinary sample collected in 2013
Who cannot join
- Patients suffering from an autoimmune disease associated with the diabetes (vitiligo, Grave's disease, thyroiditis, pernicious anemia or Biermer's disease)
- Patient with a renal disease (other than diabetic nephropathy) at the first urinary collection (between 2004 and 2008)
- Pregnancy, because the urinary proteome and the microalbumin dosage can be modified during a pregnancy.
- Patient refusal to use urinary samples already collected
Trial locations and contacts
2 sites in 1 country.
France2 sites
Purpan Children Hospital
Toulouse, 31059
Rangueil Hospital
Toulouse, 31059
About this study
Official title: Identification and First Validation of Early Non-invasive Biomarkers of Diabetic Nephropathy in Type I Diabetic Children
About 30 to 40% of patients suffering from type I diabetes are at risk of developing a diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease. Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset of DN. However, it is a late (because it permits to detect a renal disease already present), non-specific and low sensitive biomarker.
Therefore the main objective of this study is to identify early urinary biomarkers predictive of DN in children with type I diabetes, before the appearance of a microalbuminuria.
Read the detailed description
Once the type I diabetes is diagnosed, the speed of progression to a DN is very variable. Thus, the discovery of biomarkers able to distinguish progressor patients from non-progressor since the appearance of a microalbuminuria, is crucial in order to take care of progressor patients the earlier and to slow down the disease progression.
The investigators have shown that urine is a biological sample extremely well suited for proteome analysis with the aim to identify biomarkers of renal damages. Indeed, they were the first to analyze the urinary proteome of infant using capillary electrophoresis-coupled mass spectrometry. This technic permits to analyse the entire urinary proteome of a person in one hour.
Several laboratories tried to identify other predictive urinary biomarkers of the development of a DN in diabetic patients, but with limited success and nowadays in the clinical practice they still use the measure of the microalbuminuria. Contrary to precedent studies, the investigators develop an analysis without a priori and starting with early samples (without any signs of DN) associating the urinary peptide profile with the DN progression over 9-10 years.
This is a nested case-control study in a cohort of 317 patients constituting the urinary biological collection. (The urinary samples of a type I diabetic cohort of 317 patients seen between 2004 and 2008 have been collected.) These patients will be contacted at the end of 2012 to obtain a number of participation of 180 patients authorizing the use aposteriori of their urinary samples. Among this cohort, the investigators evaluate at 90 the number of patients with a DN defined by a dosage of microalbuminuria higher than 100 mg/L.
The primary endpoint of this study is therefore the identification of urinary biomarkers predictive of DN in type I diabetes pediatric patients.
The secondary endpoints are :
- The estimation of sensibility and specificity parameters, and the Area Under the Curve (AUC).
- The identification of factors associated with the variability of biomarkers expression such as the age at the moment of the diagnosis, the time between the diagnosis and the urinary collection, the rate of microalbuminuria, and the type of insulin used by the patient.
- And in the subgroup of patients for whom two urinary samples have been collected, the investigators want to study the urinary proteome stability in patients with no DN in 2013.
- Being tested
- Urinary sample collection
- Keywords
- Microalbuminuria, diabetic nephropathy, type I diabetes, early predictive urinary biomarkers
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary sample collectionOther
urinary sample collection will be done at the inclusion visit for the assessment of the microalbuminuria ( < or > than 100mg/L)
| Study group | Role | What they receive |
|---|---|---|
| Progressor (ND) | Group of patients with an albuminuria > 100mg/L, by Urinary sample collection Receives: Other: Urinary sample collection | |
| Non-Progressor (non-ND) | Group of patients without an albuminuria > 100mg/L, by Urinary sample collection Receives: Other: Urinary sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify predictive non-invasive urinary biomarkers
Urinary samples collection Assessment of the microalbuminuria to diagnose the diabetic nephropathy (DN)
Measured: Baseline (Inclusion day)
Secondary outcomes (1)
Relation of urinary markers with patient characteristics
Patients characteristics : age of the patients at the diabetes diagnosis, their age at the urinary collection, their sex, the time between the diagnosis and the urinary collection, the type of insulin used.
Measured: Baseline (Inclusion day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2013
- Primary completion25 May 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus With Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory Inserm U858 Team 5 - RF-lab
- Responsible party
- Sponsor
- Investigators
- Stephane DECRAMER, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164279
- Sponsor's protocol ID
- 12 356 03
- Other IDs
- 2012-A01097-36
- Acronym
- peeDIAB2
- Status last verified
- Sep 2020
- First submitted
- 6 Jun 2014
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and First Validation of Early Non-invasive Biomarkers of Diabetic Nephropathy in Type I Diabetic Children
- ClinicalTrials.gov ID
- NCT02164279
- Acronym / sponsor ID
- peeDIAB2 / 12 356 03
- Keywords
- Microalbuminuria, diabetic nephropathy, type I diabetes, early predictive urinary biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Laboratory Inserm U858 Team 5 - RF-lab
- Study start
- Jun 2013
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 16 Jun 2014 (estimated)
- 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.
About 30 to 40% of patients suffering from type I diabetes are at risk of developing a diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease. Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset of DN. However, it is a late (because it permits to detect a renal disease already present), non-specific and low sensitive biomarker.
Therefore the main objective of this study is to identify early urinary biomarkers predictive of DN in children with type I diabetes, before the appearance of a microalbuminuria.
Detailed description
Once the type I diabetes is diagnosed, the speed of progression to a DN is very variable. Thus, the discovery of biomarkers able to distinguish progressor patients from non-progressor since the appearance of a microalbuminuria, is crucial in order to take care of progressor patients the earlier and to slow down the disease progression.
The investigators have shown that urine is a biological sample extremely well suited for proteome analysis with the aim to identify biomarkers of renal damages. Indeed, they were the first to analyze the urinary proteome of infant using capillary electrophoresis-coupled mass spectrometry. This technic permits to analyse the entire urinary proteome of a person in one hour.
Several laboratories tried to identify other predictive urinary biomarkers of the development of a DN in diabetic patients, but with limited success and nowadays in the clinical practice they still use the measure of the microalbuminuria. Contrary to precedent studies, the investigators develop an analysis without a priori and starting with early samples (without any signs of DN) associating the urinary peptide profile with the DN progression over 9-10 years.
This is a nested case-control study in a cohort of 317 patients constituting the urinary biological collection. (The urinary samples of a type I diabetic cohort of 317 patients seen between 2004 and 2008 have been collected.) These patients will be contacted at the end of 2012 to obtain a number of participation of 180 patients authorizing the use aposteriori of their urinary samples. Among this cohort, the investigators evaluate at 90 the number of patients with a DN defined by a dosage of microalbuminuria higher than 100 mg/L.
The primary endpoint of this study is therefore the identification of urinary biomarkers predictive of DN in type I diabetes pediatric patients.
The secondary endpoints are :
- The estimation of sensibility and specificity parameters, and the Area Under the Curve (AUC).
- The identification of factors associated with the variability of biomarkers expression such as the age at the moment of the diagnosis, the time between the diagnosis and the urinary collection, the rate of microalbuminuria, and the type of insulin used by the patient.
- And in the subgroup of patients for whom two urinary samples have been collected, the investigators want to study the urinary proteome stability in patients with no DN in 2013.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressor (ND) | – | Other: Urinary sample collectionGroup of patients with an albuminuria > 100mg/L, by Urinary sample collection |
| Non-Progressor (non-ND) | – | Other: Urinary sample collectionGroup of patients without an albuminuria > 100mg/L, by Urinary sample collection |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients are selected in a cohort of 317 type I diabetic children constituting a urine samples collection. Indeed, urine sample of 317 patients have been collected between 2004 and 2008. These patients will be called to obtain the participation of 180 children in this study.
Key inclusion criteria (6 listed)
- Patient with a type I diabetes diagnosed before 15 years-old
- Urinary collection done 5 years after the diagnosis
- Urinary collection done without any acute intermittent pathology
- Urinary collection done without any treatment (other than diabetes treatment)
- Glomerular filtration rate ≥ 60 mL/min at the moment of the urinary collection already done
Key exclusion criteria (4 listed)
- Patients suffering from an autoimmune disease associated with the diabetes (vitiligo, Grave's disease, thyroiditis, pernicious anemia or Biermer's disease)
- Patient with a renal disease (other than diabetic nephropathy) at the first urinary collection (between 2004 and 2008)
- Pregnancy, because the urinary proteome and the microalbumin dosage can be modified during a pregnancy.
- Patient refusal to use urinary samples already collected
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 |
|---|---|---|
| Urinary sample collectionurinary sample collection will be done at the inclusion visit for the assessment of the microalbuminuria ( < or > than 100mg/L) | Other | Non-Progressor (non-ND), Progressor (ND) |
Primary outcome
Identify predictive non-invasive urinary biomarkers
Time frame: Baseline (Inclusion day)
Urinary samples collection Assessment of the microalbuminuria to diagnose the diabetic nephropathy (DN)
1 secondary outcome
Relation of urinary markers with patient characteristics
Time frame: Baseline (Inclusion day)
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 23 Sep 2020.
Related trials for Type 1 Diabetes Mellitus With Diabetic Nephropathy
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
Not yet recruitingPhase 2
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Type 1 Diabetes Mellitus With Diabetic Nephropathy
RecruitingObservational study
Patients With Type 2 Diabetes
Diabetes Mellitus Type 2
Active, not recruitingObservational study
Prospective Decision Impact Trial of KidneyIntelX
Diabetic Kidney Disease, Chronic Kidney Disease Stage 1
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.
Stephane DECRAMER, PhD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus With Diabetic Nephropathy, run by University Hospital, Toulouse at 2 sites 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 6 inclusion and 4 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 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Identify predictive non-invasive urinary biomarkers (time frame: Baseline (Inclusion day)). 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 23 Sep 2020.