NCT06187129

Brief Summary

Aim of study: To evaluate accuracy of nerve ultrasound in detecting clinical and subclinical peripheral neuropathy in children and adolescents diagnosed with type 1 diabetes melitus .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

December 16, 2023

Last Update Submit

January 27, 2024

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

  • cross sectional area of peripheral nerves using nerve ultrasound

    To evaluate accuracy of nerve ultrasound in detecting clinical and subclinical peripheral neuropathy in children and adolescents diagnosed with type 1 diabetes melitus .

    baseline

Study Arms (2)

diabetic children and adolescent with type 1 diabetes

nerve ultrasound and nerve conduction study

Device: nerve ultrasound

healthy age matched group

nerve ultrasound

Device: nerve ultrasound

Interventions

nerve ultrasoundDEVICE

nerve ultrasound

Also known as: nerve conduction study
diabetic children and adolescent with type 1 diabeteshealthy age matched group

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

1. Children and adolescents aged 8-17 y diagnosed as type 1 DM according to American diabetes association ( ADA) (17) . 2. On multiple injection or insulin pump for at least 5 years or more. 3. Patients are free from acute complication like diabetes ketoacidosis (DKA), symptomatic hypoglycemia, or infection for at least one month before enrollment in the study.

You may qualify if:

  • \- 1.Children and adolescents aged 8-17 y diagnosed as type 1 DM according to American diabetes association ( ADA) (17) .
  • On multiple injection or insulin pump for at least 5 years or more. 3.Patients are free from acute complication like diabetes ketoacidosis (DKA), symptomatic hypoglycemia, or infection for at least one month before enrollment in the study.

You may not qualify if:

  • Age less than 8 years or more than 17 years. 2.Diabetes other than T1DM . 3.Patients with known neuropathy of any other cause rather than diabetes. 4.Diabetic children with thyroid dysfunction ,coelic disease or anemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Donaghue KC, Marcovecchio ML, Wadwa RP, Chew EY, Wong TY, Calliari LE, Zabeen B, Salem MA, Craig ME. ISPAD Clinical Practice Consensus Guidelines 2018: Microvascular and macrovascular complications in children and adolescents. Pediatr Diabetes. 2018 Oct;19 Suppl 27(Suppl 27):262-274. doi: 10.1111/pedi.12742. No abstract available.

    PMID: 30079595BACKGROUND

  • Charles M, Soedamah-Muthu SS, Tesfaye S, Fuller JH, Arezzo JC, Chaturvedi N, Witte DR; EURODIAB Prospective Complications Study Investigators. Low peripheral nerve conduction velocities and amplitudes are strongly related to diabetic microvascular complications in type 1 diabetes: the EURODIAB Prospective Complications Study. Diabetes Care. 2010 Dec;33(12):2648-53. doi: 10.2337/dc10-0456. Epub 2010 Sep 7.

    PMID: 20823346BACKGROUND

  • Kallinikou D, Soldatou A, Tsentidis C, Louraki M, Kanaka-Gantenbein C, Kanavakis E, Karavanaki K. Diabetic neuropathy in children and adolescents with type 1 diabetes mellitus: Diagnosis, pathogenesis, and associated genetic markers. Diabetes Metab Res Rev. 2019 Oct;35(7):e3178. doi: 10.1002/dmrr.3178. Epub 2019 Jun 6.

    PMID: 31083769BACKGROUND

  • Dyck PJ, Albers JW, Andersen H, Arezzo JC, Biessels GJ, Bril V, Feldman EL, Litchy WJ, O'Brien PC, Russell JW; Toronto Expert Panel on Diabetic Neuropathy. Diabetic polyneuropathies: update on research definition, diagnostic criteria and estimation of severity. Diabetes Metab Res Rev. 2011 Oct;27(7):620-8. doi: 10.1002/dmrr.1226.

    PMID: 21695763BACKGROUND

  • Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

    PMID: 20876709BACKGROUND

  • Altuwaijri WA, Almutair AN, AlAlwan IA, Almahdi MJ, Almasoud SD. Subclinical Neuropathy in Children With Type I Diabetes Mellitus: Tertiary Care Centre Experience. Cureus. 2022 Aug 8;14(8):e27765. doi: 10.7759/cureus.27765. eCollection 2022 Aug.

    PMID: 35949448BACKGROUND

  • Walter-Holiner I, Barbarini DS, Lutschg J, Blassnig-Ezeh A, Zanier U, Saely CH, Simma B. High Prevalence and Incidence of Diabetic Peripheral Neuropathy in Children and Adolescents With Type 1 Diabetes Mellitus: Results From a Five-Year Prospective Cohort Study. Pediatr Neurol. 2018 Mar;80:51-60. doi: 10.1016/j.pediatrneurol.2017.11.017. Epub 2017 Dec 13.

    PMID: 29429781BACKGROUND

  • Yu Y. Gold Standard for Diagnosis of DPN. Front Endocrinol (Lausanne). 2021 Oct 26;12:719356. doi: 10.3389/fendo.2021.719356. eCollection 2021.

    PMID: 34764937BACKGROUND

  • Misra UK, Kalita J, Nair PP. Diagnostic approach to peripheral neuropathy. Ann Indian Acad Neurol. 2008 Apr;11(2):89-97. doi: 10.4103/0972-2327.41875.

    PMID: 19893645BACKGROUND

  • Karsidag S, Morali S, Sargin M, Salman S, Karsidag K, Us O. The electrophysiological findings of subclinical neuropathy in patients with recently diagnosed type 1 diabetes mellitus. Diabetes Res Clin Pract. 2005 Mar;67(3):211-9. doi: 10.1016/j.diabres.2004.07.017.

    PMID: 15713353BACKGROUND

  • 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.

    PMID: 26905353BACKGROUND

  • Singh DP, Singh P, Sharma S, Aneja S, Seth A. Point Prevalence of Peripheral Neuropathy in Children and Adolescents with Type 1 Diabetes Mellitus. Indian J Pediatr. 2022 Mar;89(3):220-225. doi: 10.1007/s12098-021-03742-4. Epub 2021 Jun 10.

    PMID: 34109557BACKGROUND

  • Yusuf I, Mork H, Erdlenbruch B, Schellinger PD, Philipps J. Nerve ultrasound reference values in children and adolescents: Echogenicity and influence of anthropometric factors including hand volume. J Cent Nerv Syst Dis. 2023 Aug 21;15:11795735231195778. doi: 10.1177/11795735231195778. eCollection 2023.

    PMID: 37621670BACKGROUND

  • Pitarokoili K, Gold R, Fisse AL. Nerve ultrasound for the diagnosis and follow-up of peripheral neuropathies. Curr Opin Neurol. 2023 Oct 1;36(5):373-381. doi: 10.1097/WCO.0000000000001183. Epub 2023 Jun 23.

    PMID: 37382111BACKGROUND

  • 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.

    PMID: 27028140BACKGROUND

  • Chiang JL, Maahs DM, Garvey KC, Hood KK, Laffel LM, Weinzimer SA, Wolfsdorf JI, Schatz D. Type 1 Diabetes in Children and Adolescents: A Position Statement by the American Diabetes Association. Diabetes Care. 2018 Sep;41(9):2026-2044. doi: 10.2337/dci18-0023. Epub 2018 Aug 9. No abstract available.

    PMID: 30093549BACKGROUND

  • Ryan CS, Conlee EM, Sharma R, Sorenson EJ, Boon AJ, Laughlin RS. Nerve conduction normal values for electrodiagnosis in pediatric patients. Muscle Nerve. 2019 Aug;60(2):155-160. doi: 10.1002/mus.26499. Epub 2019 May 11.

    PMID: 31032944BACKGROUND

  • Grimm AS, Schubert C, Grimm A, Stahl JH, Kupper H, Horber V, Kegele J, Willikens S, Wittlinger J, Serna-Higuita L, Winter N, Groeschel S. Normative Observational Nerve Ultrasound Values in School-Age Children and Adolescents and Their Application to Hereditary Neuropathies. Front Neurol. 2020 Apr 28;11:303. doi: 10.3389/fneur.2020.00303. eCollection 2020.

    PMID: 32411079BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

Esraa H Hosny Dahy Hassan

CONTACT

01064080903esraahosny@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

December 16, 2023

First Posted

January 2, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

January 30, 2024

Record last verified: 2024-01