NCT02164279

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2016

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

June 6, 2014

Last Update Submit

September 21, 2020

Conditions

Type 1 Diabetes Mellitus With Diabetic Nephropathy

Keywords

Microalbuminuriadiabetic nephropathytype I diabetesearly predictive urinary biomarkers

Outcome Measures

Primary Outcomes (1)

  • Identify predictive non-invasive urinary biomarkers

    Urinary samples collection Assessment of the microalbuminuria to diagnose the diabetic nephropathy (DN)

    Baseline (Inclusion day)

Secondary Outcomes (1)

  • Relation of urinary markers with patient characteristics

    Baseline (Inclusion day)

Study Arms (2)

Progressor (ND)

Group of patients with an albuminuria \> 100mg/L, by Urinary sample collection

Other: Urinary sample collection

Non-Progressor (non-ND)

Group of patients without an albuminuria \> 100mg/L, by Urinary sample collection

Other: Urinary sample collection

Interventions

Urinary sample collectionOTHER

urinary sample collection will be done at the inclusion visit for the assessment of the microalbuminuria ( \< or \> than 100mg/L)

Non-Progressor (non-ND)Progressor (ND)

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Purpan Children Hospital

Toulouse, 31059, France

Location

Rangueil Hospital

Toulouse, 31059, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Stephane DECRAMER, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 16, 2014

Study Start

June 1, 2013

Primary Completion

May 25, 2016

Study Completion

May 25, 2016

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations

FR(2)