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NCT Number: NCT04257877

Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

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.

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Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Peripheral Neuropathy Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Proteomics

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Location status: Recruiting

Location contact

Assimina Galli-Tsinopoulou, MD, PhD

CONTACT

[email protected]

+302310991537

Eleni Litou, MD

CONTACT

[email protected]

Spiros Garbis, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Medication

Treatment and study plan

blood sampling

Procedure

Blood samples for proteomic analysis in plasma of both groups

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: 2018-2020

Secondary outcomes

  1. Electrophysiological study

    Time frame: 2018-2020

    electrophysiological findings such as nerve conduction velocity indicative of peripheral neuropathy.

    • Correlation of proteomic analysis results with electrophysiological findings.

Study contacts

Contact information is provided by the study sponsor or research team.

Assimina Galli-Tsinopoulou, MD,PhD

CONTACT

[email protected]

+302310991537

Eleni Litou, MD

CONTACT

[email protected]

+302313323920

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Acronym: PAPD

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2020
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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