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Diabetes Type 1PAPDNCT04257877

Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

An observational study of Diabetes Type 1 and Proteomics, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 10 yearsHealthy volunteers can take part
What is being tested?
Blood sampling
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteGreece
Study dates
20 Nov 2018to 20 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • Presence of organic cause for neuropathy
  • Presence of other chronic disease
  • Poor glycemic control
  • 3. Medication

Trial locations and contacts

1 site in 1 country.

Assimina Galli-Tsinopoulou, MD,PhD contact

+302310991537

agalli@auth.gr

Eleni Litou, MD contact

+302313323920

eleni.li.87@gmail.com

Greece1 site, 1 recruiting

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

    Thessaloniki, 54621

    Assimina Galli-Tsinopoulou, MD, PhD, +302310991537, agalli@auth.gr

    Eleni Litou, MD, eleni.li.87@gmail.com

    Recruiting

Other trials in Greece

About this study

Official title: 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.

Being tested
Blood sampling
Keywords
plasma proteomics, children, diabetes type 1, nerve conduction
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingProcedure or surgery

    Blood samples for proteomic analysis in plasma of both groups

Study groups in NCT04257877
Study groupRoleWhat they receive
Diabetes type 1Patients= diabetes type1
Receives: Procedure: Blood sampling
Healthy participantsHealthy participants = Control group
Receives: Procedure: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 2018-2020

Secondary outcomes (1)

  1. Electrophysiological study

    electrophysiological findings such as nerve conduction velocity indicative of peripheral neuropathy.

    • Correlation of proteomic analysis results with electrophysiological findings.

    Measured: 2018-2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start20 Nov 2018
  3. Primary completion20 Jan 2025 (estimated)
  4. Study completion20 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04257877
Sponsor's protocol ID
1.109/21.11.2018
Acronym
PAPD
Status last verified
Jul 2024
First submitted
31 Jan 2020
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8403830

  • Donaghue KC, Silink M. Diabetic neuropathy in childhood. Diabetes Nutr Metab. 1999 Apr;12(2):154-60. No abstract available.

    PubMed 10554898

  • Otto-Buczkowska E, Kazibutowska Z, Soltyk J, Machnica L. Neuropathy and type 1 diabetes mellitus. Pediatr Endocrinol Diabetes Metab. 2008;14(2):109-16.

    PubMed 18721498

  • 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.

    PubMed 9507409

  • 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.

    PubMed 25153576

  • 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.

    PubMed 22503144

  • 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.

    PubMed 20150297

  • 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.

    PubMed 9545124

  • 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.

    PubMed 4075949

  • 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.

    PubMed 6825977

  • 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.

    PubMed 8243820

  • 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.

    PubMed 4029512

  • 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.

    PubMed 16459455

  • 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.

    PubMed 20723100

  • 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.

    PubMed 23723354

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Type 1 and Proteomics, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Assimina Galli-Tsinopoulou, MD,PhD (+302310991537, agalli@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04257877, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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