Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Aristotle University Of Thessaloniki

Status: Enrolling

Conditions: Proteomics; Diabetes Type 1; Diabetic Peripheral Neuropathy

Treatments: Procedure: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04257877

1.109/21.11.2018

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

4. Medication

Trial design

50 participants in 2 patient groups

Diabetes type 1

Description:

Patients= diabetes type1

Treatment:

Procedure: Blood sampling

Healthy participants

Description:

Healthy participants = Control group

Treatment:

Procedure: Blood sampling