Clinical trial NCT04257877: Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)
Official title: Targeted Proteomic Analysis in the Plasma of Children With Diabetes Type 1 and Its Association With Peripheral Diabetic Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Type 1
Proteomics
Diabetic Peripheral Neuropathy
Keywords: plasma proteomics
children
diabetes type 1
nerve conduction
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetes type 1 group

* Good glycemic control with HbA1c ≤ 7.0%
* Prepubertal patients (stage Tanner I :

Estradiol E2 \< 15pg/dl for girls, Testosterone T \< 10ng/dl for boys)

Healthy participants group:

* Age 5-10 years
* No medication
* No acute or chronic disease

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 2018-2020
Secondary outcomes:
measure: Electrophysiological study
timeFrame: 2018-2020
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Pediatric Endocrinology, Diabetes and Metabolism-2nd Department of Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki
Study officials:
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