Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04257877
Acronym
PAPD
Enrollment
50
Registered
2020-02-06
Start date
2018-11-20
Completion date
2025-01-20
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 1, Diabetic Peripheral Neuropathy, Proteomics

Keywords

plasma proteomics, children, diabetes type 1, nerve conduction

Brief 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.

Interventions

PROCEDUREBlood sampling

Blood samples for proteomic analysis in plasma of both groups

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes

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 criteria

1. Presence of organic cause for neuropathy 2. Presence of other chronic disease 3. Poor glycemic control 3\. Medication

Design outcomes

Primary

MeasureTime frame
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)2018-2020

Secondary

MeasureTime frameDescription
Electrophysiological study2018-2020electrophysiological findings such as nerve conduction velocity indicative of peripheral neuropathy. \- Correlation of proteomic analysis results with electrophysiological findings.

Countries

Greece

Contacts

Primary ContactAssimina Galli-Tsinopoulou, MD,PhD
agalli@auth.gr+302310991537
Backup ContactEleni Litou, MD
eleni.li.87@gmail.com+302313323920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026