Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Study Overview
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Brief Summary
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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.

Official Title
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Targeted Proteomic Analysis in the Plasma of Children With Diabetes Type 1 and Its Association With Peripheral Diabetic Neuropathy

Conditions
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Diabetes Type 1, Proteomics, Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with confirmed DT1 under insulin substitution therapy Age 5-10 years Good glycemic control with HbA1c ≤ 7.0% Prepubertal patients Absence of other diseases Signed informed consent of the parents or guardians of patients Exclusion Criteria: Presence of organic cause for neuropathy Presence of other chronic disease Poor glycemic control 3. Medication

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes type 1<br>Patients= diabetes type1 | Procedure: Blood sampling<br>* Blood samples for proteomic analysis in plasma of both groups<br>|
| Healthy participants<br>Healthy participants = Control group | Procedure: Blood sampling<br>* Blood samples for proteomic analysis in plasma of both groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological study | electrophysiological findings such as nerve conduction velocity indicative of peripheral neuropathy. - Correlation of proteomic analysis results with electrophysiological findings. | 2018-2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma proteomics, children, diabetes type 1, nerve conduction