Analyzing blood proteins in children with type 1 diabetes
Targeted Proteomic Analysis in the Plasma of Children With Diabetes Type 1 and Its Association With Peripheral Diabetic Neuropathy
This study is trying to find blood markers in young children with type 1 diabetes to see if they can help spot early signs of nerve damage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 5 Years to 10 Years |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki) |
| Trial ID | NCT04257877 on ClinicalTrials.gov |
What this trial studies
This observational study aims to conduct a targeted proteomic analysis of plasma in children of Greek origin diagnosed with type 1 diabetes (T1D). The researchers will correlate these proteomic findings with electrophysiological assessments, specifically nerve conduction studies, to identify early signs of diabetic peripheral neuropathy. The study focuses on children aged 5-10 years who are under insulin therapy and have good glycemic control. By identifying biomarkers through this analysis, the study seeks to enhance early detection of neuropathy in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-10 years with confirmed type 1 diabetes who are under insulin therapy and maintain good glycemic control.
Not a fit: Patients with other chronic diseases or those with poor glycemic control may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and intervention for diabetic peripheral neuropathy in children with type 1 diabetes.
How similar studies have performed: While diabetic neuropathy is commonly studied in adults, this specific approach using proteomic analysis in children is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children with confirmed DT1 under insulin substitution therapy 2. Age 5-10 years 3. Good glycemic control with HbA1c ≤ 7.0% 4. Prepubertal patients 5. Absence of other diseases 6. Signed informed consent of the parents or guardians of patients Exclusion Criteria: 1. Presence of organic cause for neuropathy 2. Presence of other chronic disease 3. Poor glycemic control 3\. Medication
Where this trial is running
Thessaloniki
- Unit of Pediatric Endocrinology, Diabetes and Metabolism-2nd Department of Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki — Thessaloniki, Greece (Recruiting)
Study contacts
- Study coordinator: Assimina Galli-Tsinopoulou, MD,PhD
- Email: agalli@auth.gr
- Phone: +302310991537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.