Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Recruiting

• Conditions: Diabetes Type 1; Diabetic Peripheral Neuropathy; Proteomics
• Interventions: Procedure: Blood sampling

• Registration Number: NCT04257877
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The aim of the present study is to investigate a targeted proteomic analysis in plasma of children - of Greek origin- with type 1 diabetes (DT1) and its correlation with the electrophysiological findings that accompany diabetic peripheral neuropathy.

Diabetic neuropathy is the most frequent chronic complication in adults with DT1 and rarely appears in childhood. Nevertheless, cases of acute mononeuritis have been described at the time of diagnosis of DT1. According to recent reports several biomarkers, including proteomic analysis, have been proposed for the early detection of peripheral neuropathy in children and young adults with T1DM.

In the present study the researchers will attempt to investigate the role of biomarkers with targeted proteomic analysis in the plasma of children with DT1 in combination with an electrophysiological study, which includes a nerve conduction study, to detect early diabetic peripheral neuropathy, before the appearance of clinical manifestations.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

4. Medication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes type 1	Blood sampling	Patients= diabetes type1
Healthy participants	Blood sampling	Healthy participants = Control group

Primary Outcome Measures

Name	Time	Method
Targeted proteomic analysis in children with DT1 (levels of certain plasma proteomics such as sorbitol, fructose, myo-inositol, scyllo-inositol, serine, lysine, tertadecanoic, palmitic, stearic, eicosanoic fatty acids)	2018-2020

Secondary Outcome Measures

Name	Time	Method
Electrophysiological study	2018-2020	electrophysiological findings such as nerve conduction velocity indicative of peripheral neuropathy.; - Correlation of proteomic analysis results with electrophysiological findings.

Trial Locations

Locations (1)

Unit of Pediatric Endocrinology, Diabetes and Metabolism-2nd Department of Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece