Validation of Biomarkers of Diabetic Nephropathy in Type I Diabetic Children (NCT02164279) | Clinical Trial Compass
CompletedNot Applicable
Validation of Biomarkers of Diabetic Nephropathy in Type I Diabetic Children
France150 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range
6 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.