Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD) (PAPD)

July 20, 2023 updated by: Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Assimina Galli-Tsinopoulou, MD,PhD
  • Phone Number: +302310991537
  • Email: agalli@auth.gr

Study Contact Backup

Study Locations

  • Greece
      • Thessaloniki, Greece, 54621
        • Recruiting
        • Unit of Pediatric Endocrinology, Diabetes and Metabolism-2nd Department of Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki
        • Contact:
          • Assimina Galli-Tsinopoulou, MD, PhD
          • Phone Number: +302310991537
          • Email: agalli@auth.gr
        • Contact:
        • Sub-Investigator:
          • Spiros Garbis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetes type 1
Patients= diabetes type1
Procedure: Blood sampling
Blood samples for proteomic analysis in plasma of both groups
Healthy participants
Healthy participants = Control group
Procedure: Blood sampling
Blood samples for proteomic analysis in plasma of both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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)
Time Frame: 2018-2020
2018-2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2018-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Estimated)

July 20, 2024

Study Completion (Estimated)

July 20, 2024

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.109/21.11.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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