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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04257877
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Information provided by (Responsible Party):
Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki

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.

Condition or disease Intervention/treatment
Diabetes Type 1 Proteomics Diabetic Peripheral Neuropathy Procedure: Blood sampling

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Targeted Proteomic Analysis in the Plasma of Children With Diabetes Type 1 and Its Association With Peripheral Diabetic Neuropathy
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 20, 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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) [ Time Frame: 2018-2020 ]

Secondary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
Proteomics in plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04257877

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Contact: Assimina Galli-Tsinopoulou, MD,PhD +302310991537
Contact: Eleni Litou, MD +302313323920

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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 Recruiting
Thessaloniki, Greece, 54621
Contact: Assimina Galli-Tsinopoulou, MD, PhD    +302310991537   
Contact: Eleni Litou, MD   
Sub-Investigator: Spiros Garbis, PhD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki

Additional Information:

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Responsible Party: Assimina Galli-Tsinopoulou, Professor, Aristotle University Of Thessaloniki Identifier: NCT04257877    
Other Study ID Numbers: 1.109/21.11.2018
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki:
plasma proteomics
diabetes type 1
nerve conduction
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases