Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)
NCT ID: NCT04257877
Last Updated: 2024-07-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-11-20
Study Completion Date
2025-01-20
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Diabetes Type 1
Proteomics
Diabetic Peripheral Neuropathy
Study Design
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Observational Model Type
OTHER
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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Diabetes type 1
Patients= diabetes type1
Blood sampling
Intervention Type
PROCEDURE
Blood samples for proteomic analysis in plasma of both groups
Healthy participants
Healthy participants = Control group
Blood sampling
Intervention Type
PROCEDURE
Blood samples for proteomic analysis in plasma of both groups
Interventions
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Blood sampling
Blood samples for proteomic analysis in plasma of both groups
Intervention Type
PROCEDURE
Eligibility Criteria
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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
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
2. Presence of other chronic disease
3. Poor glycemic control
3\. Medication
Minimum Eligible Age
5 Years
Maximum Eligible Age
10 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Sponsor Role
lead
Responsible Party
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Assimina Galli-Tsinopoulou
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Unit of Pediatric Endocrinology, Diabetes and Metabolism-2nd Department of Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki
Thessaloniki, , Greece
Site Status
RECRUITING
Countries
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Greece
Central Contacts
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Facility Contacts
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References
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Related Links
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https://www.southampton.ac.uk/medicine/research/staff/sdg2e11.page
Spiros Garbis, Associate Professor , Head of Proteomics Unit for Cancer Sciences, Centre for Proteomics Research, Institute for Life Sciences, UK
Other Identifiers
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1.109/21.11.2018
Identifier Type: -
Identifier Source: org_study_id
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