RecruitingNCT04257877

Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

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


Sponsor

Aristotle University Of Thessaloniki

Enrollment

50 participants

Start Date

Nov 20, 2018

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 10 Years

Inclusion Criteria6

  • 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 Criteria4

  • Presence of organic cause for neuropathy
  • Presence of other chronic disease
  • Poor glycemic control
  • \. Medication

Interventions

PROCEDUREBlood sampling

Blood samples for proteomic analysis in plasma of both groups


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

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NCT04257877


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