Actively Recruiting

Age: 5Years - 10Years
All Genders
Healthy Volunteers
ID04257877

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

Led by Aristotle University Of Thessaloniki · Updated on 2024-07-31

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying children of Greek origin aged 5 to 10 years with type 1 diabetes (DT1) to explore how proteins in their blood relate to early signs of diabetic peripheral neuropathy. This condition is a common complication in adults with DT1 but is rare in children. The study aims to identify specific protein markers in plasma alongside nerve function tests to detect neuropathy before symptoms appear. Participants include children with confirmed DT1 under insulin treatment and a healthy control group. Blood samples are taken from both groups for detailed protein analysis. Additionally, children with DT1 undergo an electrophysiological nerve conduction study to assess nerve function. The study runs from 2018 to 2020, focusing on specific plasma proteins and nerve testing results. During the study, children will have blood drawn for protein analysis and undergo nerve conduction tests. Researchers will monitor levels of various proteins such as sorbitol, fructose, and several fatty acids in plasma. The goal is to correlate these findings with nerve function to detect early neuropathy. The study involves informed consent from parents or guardians and monitors glycemic control and health status throughout participation.

CONDITIONS

Brief Title

Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Who Can Participate

Age: 5Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with confirmed type 1 diabetes receiving insulin therapy
  • Age between 5 and 10 years
  • Good blood sugar control with HbA1c at or below 7.0%
  • Prepubertal status
  • No other diseases present
  • Signed informed consent from parents or guardians
Not Eligible

You will not qualify if you...

  • Presence of an organic cause for neuropathy
  • Presence of other chronic diseases
  • Poor blood sugar control
  • Current medication that may affect results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 years

Participants undergo blood sampling for proteomic analysis and electrophysiological studies to assess diabetes and peripheral neuropathy.

1 to 2 visits depending on participant group

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored over time to observe proteomic changes and neuropathy progression.

Follow-up visits as scheduled during the study period

Trial Site Locations

Total: 1 location

1

Unit of Pediatric Endocrinology, Diabetes and Metabolism-2nd Department of Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki

Thessaloniki, Greece, 54621

Actively Recruiting

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Research Team

A

Assimina Galli-Tsinopoulou, MD,PhD

E

Eleni Litou, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Effect of prior intensive insulin treatment during the Diabetes Control and Complications Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Diabetes Interventions and Complications (EDIC) Study.

James W Albers, William H Herman, Rodica Pop-Busui...

https://pubmed.ncbi.nlm.nih.gov/20150297

Free and lipid inositol, sorbitol and sugars in sciatic nerve obtained post-mortem from diabetic patients and control subjects.

J A Mayhew, K R Gillon, J N Hawthorne

https://pubmed.ncbi.nlm.nih.gov/6825977