Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

Diabetic Peripheral Neuropathy Clinical Trial

— PAPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257877
• Other study ID #: 1.109/21.11.2018
• Status: Recruiting
• Start date: November 20, 2018
• Est. completion date: July 20, 2024

Study information

• Verified date: July 2023
• Source: Aristotle University Of Thessaloniki
• Contact: Assimina Galli-Tsinopoulou, MD,PhD
• Phone: +302310991537
• Email: agalli[@]auth.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Type 1
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases
• Proteomics

Intervention

Procedure:
• Blood sampling
Blood samples for proteomic analysis in plasma of both groups

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (36)

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Albers JW, Herman WH, Pop-Busui R, Martin CL, Cleary P, Waberski B; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Intervention and Complications (EDIC) Research Group. Subclinical neuropathy among Diabetes Control and Complications Trial participants without diagnosable neuropathy at trial completion: possible predictors of incident neuropathy? Diabetes Care. 2007 Oct;30(10):2613-8. doi: 10.2337/dc07-0850. Epub 2007 Jul 20. — View Citation

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Balderas C, Ruperez FJ, Ibanez E, Senorans J, Guerrero-Fernandez J, Casado IG, Gracia-Bouthelier R, Garcia A, Barbas C. Plasma and urine metabolic fingerprinting of type 1 diabetic children. Electrophoresis. 2013 Oct;34(19):2882-90. doi: 10.1002/elps.201300062. Epub 2013 Sep 10. — View Citation

Balderas C, Villasenor A, Garcia A, Ruperez FJ, Ibanez E, Senorans J, Guerrero-Fernandez J, Gonzalez-Casado I, Gracia-Bouthelier R, Barbas C. Metabolomic approach to the nutraceutical effect of rosemary extract plus Omega-3 PUFAs in diabetic children with capillary electrophoresis. J Pharm Biomed Anal. 2010 Dec 15;53(5):1298-304. doi: 10.1016/j.jpba.2010.07.034. Epub 2010 Jul 30. — View Citation

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Godzien J, Ciborowski M, Angulo S, Ruperez FJ, Martinez MP, Senorans FJ, Cifuentes A, Ibanez E, Barbas C. Metabolomic approach with LC-QTOF to study the effect of a nutraceutical treatment on urine of diabetic rats. J Proteome Res. 2011 Feb 4;10(2):837-44. doi: 10.1021/pr100993x. Epub 2010 Dec 20. — View Citation

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Vallejo M, Angulo S, Garcia-Martinez D, Garcia A, Barbas C. New perspective of diabetes response to an antioxidant treatment through metabolic fingerprinting of urine by capillary electrophoresis. J Chromatogr A. 2008 Apr 11;1187(1-2):267-74. doi: 10.1016/j.chroma.2008.02.024. Epub 2008 Feb 12. — View Citation

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Zhang S, Nagana Gowda GA, Asiago V, Shanaiah N, Barbas C, Raftery D. Correlative and quantitative 1H NMR-based metabolomics reveals specific metabolic pathway disturbances in diabetic rats. Anal Biochem. 2008 Dec 1;383(1):76-84. doi: 10.1016/j.ab.2008.07.041. Epub 2008 Aug 20. Erratum In: Anal Biochem. 2009 Feb 15;385(2):392. — View Citation

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Electrophysiological study	electrophysiological findings such as nerve conduction velocity indicative of peripheral neuropathy.; - Correlation of proteomic analysis results with electrophysiological findings.	2018-2020

External Links

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