Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

NCT04257877 | Recruiting

• 1 other identifier: 1.109/21.11.2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 1; Proteomics; Diabetic Peripheral Neuropathy

Keywords

plasma proteomics; children; diabetes type 1; nerve conduction

Outcome Measures

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)

  2018-2020

Secondary Outcomes (1)

• Electrophysiological study

  2018-2020

Study Arms (2)

Diabetes type 1

Patients= diabetes type1

Procedure: Blood sampling

Healthy participants

Healthy participants = Control group

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

Blood samples for proteomic analysis in plasma of both groups

Diabetes type 1; Healthy participants

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• Presence of organic cause for neuropathy
• Presence of other chronic disease
• Poor glycemic control
• \. Medication

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

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

RECRUITING

Related Publications (36)

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Related Links

• Spiros Garbis, Associate Professor , Head of Proteomics Unit for Cancer Sciences, Centre for Proteomics Research, Institute for Life Sciences, UK

Biospecimen

Retention: SAMPLES WITHOUT DNA

Proteomics in plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Assimina Galli-Tsinopoulou, MD,PhD

CONTACT

+302310991537; agalli@auth.gr

Eleni Litou, MD

CONTACT

+302313323920; eleni.li.87@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: November 20, 2018
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)