- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257877
Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD) (PAPD)
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Assimina Galli-Tsinopoulou, MD,PhD
- Phone Number: +302310991537
- Email: agalli@auth.gr
Study Contact Backup
- Name: Eleni Litou, MD
- Phone Number: +302313323920
- Email: eleni.li.87@gmail.com
Study Locations
-
-
-
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:
- Eleni Litou, MD
- Email: eleni.li.87@gmail.com
-
Sub-Investigator:
- Spiros Garbis, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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:
- Children with confirmed DT1 under insulin substitution therapy
- Age 5-10 years
- Good glycemic control with HbA1c ≤ 7.0%
- Prepubertal patients
- Absence of other diseases
- Signed informed consent of the parents or guardians of patients
Exclusion Criteria:
- Presence of organic cause for neuropathy
- Presence of other chronic disease
- Poor glycemic control
3. Medication
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diabetes type 1
Patients= diabetes type1
|
Blood samples for proteomic analysis in plasma of both groups
|
Healthy participants
Healthy participants = Control group
|
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
Publications and helpful links
General Publications
- Lanza IR, Zhang S, Ward LE, Karakelides H, Raftery D, Nair KS. Quantitative metabolomics by H-NMR and LC-MS/MS confirms altered metabolic pathways in diabetes. PLoS One. 2010 May 10;5(5):e10538. doi: 10.1371/journal.pone.0010538.
- Suhre K, Meisinger C, Doring A, Altmaier E, Belcredi P, Gieger C, Chang D, Milburn MV, Gall WE, Weinberger KM, Mewes HW, Hrabe de Angelis M, Wichmann HE, Kronenberg F, Adamski J, Illig T. Metabolic footprint of diabetes: a multiplatform metabolomics study in an epidemiological setting. PLoS One. 2010 Nov 11;5(11):e13953. doi: 10.1371/journal.pone.0013953.
- Bain JR, Stevens RD, Wenner BR, Ilkayeva O, Muoio DM, Newgard CB. Metabolomics applied to diabetes research: moving from information to knowledge. Diabetes. 2009 Nov;58(11):2429-43. doi: 10.2337/db09-0580. No abstract available.
- Donaghue KC, Bonney M, Simpson JM, Schwingshandl J, Fung AT, Howard NJ, Silink M. Autonomic and peripheral nerve function in adolescents with and without diabetes. Diabet Med. 1993 Aug-Sep;10(7):664-71. doi: 10.1111/j.1464-5491.1993.tb00142.x.
- Donaghue KC, Silink M. Diabetic neuropathy in childhood. Diabetes Nutr Metab. 1999 Apr;12(2):154-60. No abstract available.
- Otto-Buczkowska E, Kazibutowska Z, Soltyk J, Machnica L. Neuropathy and type 1 diabetes mellitus. Pediatr Endocrinol Diabetes Metab. 2008;14(2):109-16.
- Said G, Bigo A, Ameri A, Gayno JP, Elgrably F, Chanson P, Slama G. Uncommon early-onset neuropathy in diabetic patients. J Neurol. 1998 Feb;245(2):61-8. doi: 10.1007/s004150050179.
- Rangel MA, Baptista C, Santos F, Real MV, Campos RA, Leite AL. Acute mononeuropathy in a child with newly diagnosed type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2015 Mar;28(3-4):341-4. doi: 10.1515/jpem-2014-0049.
- Louraki M, Karayianni C, Kanaka-Gantenbein C, Katsalouli M, Karavanaki K. Peripheral neuropathy in children with type 1 diabetes. Diabetes Metab. 2012 Oct;38(4):281-9. doi: 10.1016/j.diabet.2012.02.006. Epub 2012 Apr 12.
- Albers JW, Herman WH, Pop-Busui R, Feldman EL, Martin CL, Cleary PA, Waberski BH, Lachin JM; Diabetes Control and Complications Trial /Epidemiology of Diabetes Interventions and Complications Research Group. 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. Diabetes Care. 2010 May;33(5):1090-6. doi: 10.2337/dc09-1941. Epub 2010 Feb 11.
- Barkai L, Kempler P, Vamosi I, Lukacs K, Marton A, Keresztes K. Peripheral sensory nerve dysfunction in children and adolescents with type 1 diabetes mellitus. Diabet Med. 1998 Mar;15(3):228-33. doi: 10.1002/(SICI)1096-9136(199803)15:33.0.CO;2-8.
- Sosenko JM, Boulton AJ, Kubrusly DB, Weintraub JK, Skyler JS. The vibratory perception threshold in young diabetic patients: associations with glycemia and puberty. Diabetes Care. 1985 Nov-Dec;8(6):605-7. doi: 10.2337/diacare.8.6.605.
- Mayhew JA, Gillon KR, Hawthorne JN. Free and lipid inositol, sorbitol and sugars in sciatic nerve obtained post-mortem from diabetic patients and control subjects. Diabetologia. 1983 Jan;24(1):13-5. doi: 10.1007/BF00275940.
- Mistry KP, Beyer-Mears A, Diecke FP. Mechanisms for D-glucose inhibition of myo-inositol influx into rat lens. Diabetes. 1993 Dec;42(12):1737-44. doi: 10.2337/diab.42.12.1737.
- Brownlee M, Vlassara H, Cerami A. Nonenzymatic glycosylation products on collagen covalently trap low-density lipoprotein. Diabetes. 1985 Sep;34(9):938-41. doi: 10.2337/diab.34.9.938.
- Nery Ferreira BE, Silva IN, de Oliveira JT. High prevalence of diabetic polyneuropathy in a group of Brazilian children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2005 Nov;18(11):1087-94. doi: 10.1515/jpem.2005.18.11.1087.
- Lee SS, Han HS, Kim H. A 5-yr follow-up nerve conduction study for the detection of subclinical diabetic neuropathy in children with newly diagnosed insulin-dependent diabetes mellitus. Pediatr Diabetes. 2010 Dec;11(8):521-8. doi: 10.1111/j.1399-5448.2009.00636.x. Epub 2010 Aug 15. Erratum In: Pediatr Diabetes. 2011 Feb;12(1):74.
- Hyllienmark L, Alstrand N, Jonsson B, Ludvigsson J, Cooray G, Wahlberg-Topp J. Early electrophysiological abnormalities and clinical neuropathy: a prospective study in patients with type 1 diabetes. Diabetes Care. 2013 Oct;36(10):3187-94. doi: 10.2337/dc12-2226. Epub 2013 May 30.
- 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.
- Toopchizadeh V, Shiva S, Khiabani NY, Ghergherechi R. Electrophysiologic pattern and prevalence of subclinical peripheral neuropathy in children and adolescents with type I diabetes mellitus in Iran. Saudi Med J. 2016 Mar;37(3):299-303. doi: 10.15537/smj.2016.3.13625.
- Hajas G, Kissova V, Tirpakova A. A 10-yr follow-up study for the detection of peripheral neuropathy in young patients with type 1 diabetes. Pediatr Diabetes. 2016 Dec;17(8):632-641. doi: 10.1111/pedi.12382. Epub 2016 Mar 29.
- Giannopoulou EG, Garbis SD, Vlahou A, Kossida S, Lepouras G, Manolakos ES. Proteomic feature maps: a new visualization approach in proteomics analysis. J Biomed Inform. 2009 Aug;42(4):644-53. doi: 10.1016/j.jbi.2009.01.007. Epub 2009 Feb 4.
- 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.
- Wallaschofski H. What will metabolomics studies mean to endocrinology? J Endocrinol. 2012 Oct;215(1):1-2. doi: 10.1530/JOE-12-0270. Epub 2012 Jul 3. No abstract available.
- McKillop AM, Flatt PR. Emerging applications of metabolomic and genomic profiling in diabetic clinical medicine. Diabetes Care. 2011 Dec;34(12):2624-30. doi: 10.2337/dc11-0837.
- van der Kloet FM, Bobeldijk I, Verheij ER, Jellema RH. Analytical error reduction using single point calibration for accurate and precise metabolomic phenotyping. J Proteome Res. 2009 Nov;8(11):5132-41. doi: 10.1021/pr900499r.
- Dutta T, Chai HS, Ward LE, Ghosh A, Persson XM, Ford GC, Kudva YC, Sun Z, Asmann YW, Kocher JP, Nair KS. Concordance of changes in metabolic pathways based on plasma metabolomics and skeletal muscle transcriptomics in type 1 diabetes. Diabetes. 2012 May;61(5):1004-16. doi: 10.2337/db11-0874. Epub 2012 Mar 13.
- Zhang S, Zheng C, Lanza IR, Nair KS, Raftery D, Vitek O. Interdependence of signal processing and analysis of urine 1H NMR spectra for metabolic profiling. Anal Chem. 2009 Aug 1;81(15):6080-8. doi: 10.1021/ac900424c.
- 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.
- Moraes EP, Ruperez FJ, Plaza M, Herrero M, Barbas C. Metabolomic assessment with CE-MS of the nutraceutical effect of Cystoseira spp extracts in an animal model. Electrophoresis. 2011 Aug;32(15):2055-62. doi: 10.1002/elps.201000546.
- 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.
- 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.
- 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.
- Bervoets L, Massa G, Guedens W, Louis E, Noben JP, Adriaensens P. Metabolic profiling of type 1 diabetes mellitus in children and adolescents: a case-control study. Diabetol Metab Syndr. 2017 Jun 26;9:48. doi: 10.1186/s13098-017-0246-9. eCollection 2017.
- Biessels GJ, Bril V, Calcutt NA, Cameron NE, Cotter MA, Dobrowsky R, Feldman EL, Fernyhough P, Jakobsen J, Malik RA, Mizisin AP, Oates PJ, Obrosova IG, Pop-Busui R, Russell JW, Sima AA, Stevens MJ, Schmidt RE, Tesfaye S, Veves A, Vinik AI, Wright DE, Yagihashi S, Yorek MA, Ziegler D, Zochodne DW. Phenotyping animal models of diabetic neuropathy: a consensus statement of the diabetic neuropathy study group of the EASD (Neurodiab). J Peripher Nerv Syst. 2014 Jun;19(2):77-87. doi: 10.1111/jns5.12072.
- Zhang L, Yu C, Vasquez FE, Galeva N, Onyango I, Swerdlow RH, Dobrowsky RT. Hyperglycemia alters the schwann cell mitochondrial proteome and decreases coupled respiration in the absence of superoxide production. J Proteome Res. 2010 Jan;9(1):458-71. doi: 10.1021/pr900818g.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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