Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01097-36 | Registry Identifier | ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Laboratory Inserm U858 Team 5 - RF-lab | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 :
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressor (ND) | Group of patients with an albuminuria > 100mg/L, by Urinary sample collection |
| |
| Non-Progressor (non-ND) | Group of patients without an albuminuria > 100mg/L, by Urinary sample collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary sample collection | Other | urinary sample collection will be done at the inclusion visit for the assessment of the microalbuminuria ( < or > than 100mg/L) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify predictive non-invasive urinary biomarkers | Urinary samples collection Assessment of the microalbuminuria to diagnose the diabetic nephropathy (DN) | Baseline (Inclusion day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Inclusion day) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephane DECRAMER, PhD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purpan Children Hospital | Toulouse | 31059 | France | |||
| Rangueil Hospital |
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Urine
| Toulouse |
| 31059 |
| France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |