Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-10
SponsorAristotle University Of Thessaloniki
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children with confirmed DT1 under insulin substitution therapy
Age 5-10 years
Good glycemic control with HbA1c ≤ 7.0%
Prepubertal patients
Disqualifiers
Presence of organic cause for neuropathy
Presence of other chronic disease
Poor glycemic control
Trial population
Diabetes type 1 group * Good glycemic control with HbA1c ≤ 7.0% * Prepubertal patients (stage Tanner I : Estradiol E2 \< 15pg/dl for girls, Testosterone T \< 10ng/dl for boys) Healthy participants group: * Age 5-10 years * No medication * No acute or chronic disease
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Blood sampling
Procedure/SurgeryBlood samples for proteomic analysis in plasma of both groups
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Diabetes type 11 intervention
Group B: Healthy participants1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
2018-2020Secondary outcomes
1
Electrophysiological study
electrophysiological findings such as nerve conduction velocity indicative of peripheral neuropathy. \- Correlation of proteomic analysis results with electrophysiological findings.
Time frame
2018-2020Sponsors and contacts
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Source ClinicalTrials.gov