Actively Recruiting

Age: 5Years - 10Years
All Genders
Healthy Volunteers
NCT04257877

Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Led by Aristotle University Of Thessaloniki · Updated on 2024-07-31

50

Participants Needed

1

Research Sites

321 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Who Can Participate

Age: 5Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with confirmed type 1 diabetes under insulin therapy
  • Age between 5 and 10 years
  • Good blood sugar control with HbA1c ≤ 7.0%
  • Prepubertal patients
  • No other diseases present
  • Signed informed consent by parent or guardian
Not Eligible

You will not qualify if you...

  • Presence of any organic cause for neuropathy
  • Having other chronic diseases
  • Poor blood sugar control
  • Use of medications that affect study outcomes

AI-Screening

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Trial Site Locations

Total: 1 location

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, 54621

Actively Recruiting

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Research Team

A

Assimina Galli-Tsinopoulou, MD,PhD

CONTACT

E

Eleni Litou, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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