Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Last updated: July 29, 2024
Sponsor: Aristotle University Of Thessaloniki
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetic Neuropathy

Diabetes Mellitus Types I And Ii

Treatment

Blood sampling

Clinical Study ID

NCT04257877
1.109/21.11.2018
  • Ages 5-10
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Presence of organic cause for neuropathy

  2. Presence of other chronic disease

  3. Poor glycemic control

  4. Medication

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Blood sampling
Phase:
Study Start date:
November 20, 2018
Estimated Completion Date:
January 20, 2025

Connect with a study center

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

    Thessaloniki, 54621
    Greece

    Active - Recruiting

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