Peripheral NeuropathyNCT06187129
Evaluation of Nerve Ultrasound in Detecting Clinical and Subclinical Peripheral Neuropathy in Children and Adolescents With Type 1 Diabetes Mellitus
An observational study of Peripheral Neuropathy, run by Esraa Hosny Dahy.
Trial 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 . Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- nerve ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to Apr 2026
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 1.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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Nerve Ultrasound in Detecting Clinical and Subclinical Peripheral Neuropathy in Children and Adolescent With Type 1 Diabetes Mellitus
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 .
Read the detailed description
Introduction Type 1 diabetes (T1D) is a chronic disease with long-term vascular complications which include nephropathy, retinopathy, neuropathy, and macrovascular disease . In childhood and adolescence, early functional and structural vascular related abnormalities may be present a few years after the onset of the disease, so In this period intensive education and treatment may prevent or delay the onset and progression of complications.
Diabetic neuropathy (DN) is an important complication in patients with diabetes since it is related to mortality, morbidity, and a decrease in the quality of life ,as it is associated with neuropathic pain, foot ulceration, and subsequently gangrene and amputation.
Typical DPN is a chronic, nerve-length-dependent, distal symmetrical sensorimotor polyneuropathy (DSPN) and is considered as the most common form among diabetic neuropathies .
DPN can be classified into subclinical and clinical stages; based on history with sensory disturbances (possible); symptoms and/or signs of nerve dysfunction (probable); symptoms and/or signs plus abnormal gold standard test (confirmed); abnormal gold standard test (subclinical).
Subclinical neuropathy is defined as asymptomatic peripheral neuropathy, which is one of the common complications of patients with diabetes mellitus (DM). There is considerable uncertainty about the prevalence of diabetic peripheral neuropathy (DPN) in pediatric populations, which is probably due to the lack of large epidemiological studies performed on pediatric patients with DM, who often show few symptoms of neurological involvement.
Evidence from western studies have suggested that a quarter of children and adolescents with type 1 diabetes have clinical or subclinical evidence of nerve injury at diagnosis , The prevalence of peripheral neuropathy in known children with T1DM is reported to be as high as 50% .
Many risk factors have been suggested for peripheral neuropathy, such as the duration of diabetes, age at onset, height, puberty, positive family history, and diabetic complications of puberty .
The effect of chronic hyperglycemia is mediated by the increase of the intracellular level of glucose and sorbitol, which eventually leads to oxidative stress and the generation of free radicals, which damage intracellular macromolecules. In addition, chronic hyperglycemia induces the formation of advanced glycation end products (AGEs), which modify the structure of myelin, leading to axonal degeneration.
Currently, the diagnosis of DPN is mainly based on characteristic symptoms and signs. Nerve conduction studies (NCS) is one of the gold standard techniques for diagnosing DPN . It evaluates the occurrence and development of DPN by detecting the ability of peripheral nerve to transmit electrical signals in patients with DN. NCS has the characteristics of being quantifiable, objective, and sensitive, but it has the following disadvantages: time-consuming, high cost, poor experience, and the need for professional doctors to operate.
Although there are no guidelines on screening subclinical diabetic neuropathy, nerve conduction study (NCS) is the most common tool used for diagnosing it.
The pattern of nerve dysfunction has varied in neurophysiological studies on pediatric populations .Some studies found that subclinical sensory affection is prevalent. And others found that subclinical motor affection more common.
High-resolution ultrasound is of growing importance as a painless method complementary to nerve conduction studies in the workup of disorders of the peripheral nervous system, especially in children and adolescents .Cross-sectional area, echogenicity, morphology of the individual nerve fascicles, thickness of the epineurium, vascularization and mobility of the nerve are the main parameters evaluated with nerve ultrasound in polyneuropathies.
High-frequency ultrasound was first used in the clinical diagnosis of DPN as a supplement to NCS. It measures the size, blood vessels, echo, and mobility of the diseased nerve to show the damage of the nerve tissue, which can effectively improve the diagnostic efficiency of DPN and reduce the missed diagnosis rate and the misdiagnosis rate . In patients with DPN, the cross sectional area (CSA) and longitudinal section of the nerve are increased, and the echogenicity of the nerve, the boundary ambiguity, and the blood flow in the nerve are also significantly increased. The mean CSA in the examined nerves was higher in moderate to severe DPN than the mild DPN .
High resolution ultrasound has unique diagnostic advantages for early or subclinical neuropathy. High-frequency ultrasound can detect subclinical involvement of peripheral nerves and abnormalities in patients with normal electrical diagnosis .
- Conditions
- Peripheral Neuropathy
- Being tested
- nerve ultrasound
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve ultrasoundDevice
Also called nerve conduction study
nerve ultrasound
| Study group | Role | What they receive |
|---|---|---|
| diabetic children and adolescent with type 1 diabetes | nerve ultrasound and nerve conduction study Receives: Device: nerve ultrasound | |
| healthy age matched group | nerve ultrasound Receives: Device: nerve ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Hosny Dahy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esraa Hosny Dahy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187129
- Sponsor's protocol ID
- Nerve ultrasound in neuropathy
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
Publications
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.
PubMed 30079595Charles 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.
PubMed 20823346Kallinikou 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.
PubMed 31083769Dyck 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.
PubMed 21695763Tesfaye 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.
PubMed 20876709Altuwaijri 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.
PubMed 35949448Walter-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.
PubMed 29429781Yu Y. Gold Standard for Diagnosis of DPN. Front Endocrinol (Lausanne). 2021 Oct 26;12:719356. doi: 10.3389/fendo.2021.719356. eCollection 2021.
PubMed 34764937Misra 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.
PubMed 19893645Karsidag 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.
PubMed 15713353Toopchizadeh 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.
PubMed 26905353Singh 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.
PubMed 34109557Yusuf 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.
PubMed 37621670Pitarokoili 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.
PubMed 37382111Hajas 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.
PubMed 27028140
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nerve Ultrasound in Detecting Clinical and Subclinical Peripheral Neuropathy in Children and Adolescent With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06187129
- Acronym / sponsor ID
- Nerve ultrasound in neuropathy
- Conditions
- Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Esraa Hosny DahyUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Introduction Type 1 diabetes (T1D) is a chronic disease with long-term vascular complications which include nephropathy, retinopathy, neuropathy, and macrovascular disease . In childhood and adolescence, early functional and structural vascular related abnormalities may be present a few years after the onset of the disease, so In this period intensive education and treatment may prevent or delay the onset and progression of complications.
Diabetic neuropathy (DN) is an important complication in patients with diabetes since it is related to mortality, morbidity, and a decrease in the quality of life ,as it is associated with neuropathic pain, foot ulceration, and subsequently gangrene and amputation.
Typical DPN is a chronic, nerve-length-dependent, distal symmetrical sensorimotor polyneuropathy (DSPN) and is considered as the most common form among diabetic neuropathies .
DPN can be classified into subclinical and clinical stages; based on history with sensory disturbances (possible); symptoms and/or signs of nerve dysfunction (probable); symptoms and/or signs plus abnormal gold standard test (confirmed); abnormal gold standard test (subclinical).
Subclinical neuropathy is defined as asymptomatic peripheral neuropathy, which is one of the common complications of patients with diabetes mellitus (DM). There is considerable uncertainty about the prevalence of diabetic peripheral neuropathy (DPN) in pediatric populations, which is probably due to the lack of large epidemiological studies performed on pediatric patients with DM, who often show few symptoms of neurological involvement.
Evidence from western studies have suggested that a quarter of children and adolescents with type 1 diabetes have clinical or subclinical evidence of nerve injury at diagnosis , The prevalence of peripheral neuropathy in known children with T1DM is reported to be as high as 50% .
Many risk factors have been suggested for peripheral neuropathy, such as the duration of diabetes, age at onset, height, puberty, positive family history, and diabetic complications of puberty .
The effect of chronic hyperglycemia is mediated by the increase of the intracellular level of glucose and sorbitol, which eventually leads to oxidative stress and the generation of free radicals, which damage intracellular macromolecules. In addition, chronic hyperglycemia induces the formation of advanced glycation end products (AGEs), which modify the structure of myelin, leading to axonal degeneration.
Currently, the diagnosis of DPN is mainly based on characteristic symptoms and signs. Nerve conduction studies (NCS) is one of the gold standard techniques for diagnosing DPN . It evaluates the occurrence and development of DPN by detecting the ability of peripheral nerve to transmit electrical signals in patients with DN. NCS has the characteristics of being quantifiable, objective, and sensitive, but it has the following disadvantages: time-consuming, high cost, poor experience, and the need for professional doctors to operate.
Although there are no guidelines on screening subclinical diabetic neuropathy, nerve conduction study (NCS) is the most common tool used for diagnosing it.
The pattern of nerve dysfunction has varied in neurophysiological studies on pediatric populations .Some studies found that subclinical sensory affection is prevalent. And others found that subclinical motor affection more common.
High-resolution ultrasound is of growing importance as a painless method complementary to nerve conduction studies in the workup of disorders of the peripheral nervous system, especially in children and adolescents .Cross-sectional area, echogenicity, morphology of the individual nerve fascicles, thickness of the epineurium, vascularization and mobility of the nerve are the main parameters evaluated with nerve ultrasound in polyneuropathies.
High-frequency ultrasound was first used in the clinical diagnosis of DPN as a supplement to NCS. It measures the size, blood vessels, echo, and mobility of the diseased nerve to show the damage of the nerve tissue, which can effectively improve the diagnostic efficiency of DPN and reduce the missed diagnosis rate and the misdiagnosis rate . In patients with DPN, the cross sectional area (CSA) and longitudinal section of the nerve are increased, and the echogenicity of the nerve, the boundary ambiguity, and the blood flow in the nerve are also significantly increased. The mean CSA in the examined nerves was higher in moderate to severe DPN than the mild DPN .
High resolution ultrasound has unique diagnostic advantages for early or subclinical neuropathy. High-frequency ultrasound can detect subclinical involvement of peripheral nerves and abnormalities in patients with normal electrical diagnosis .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic children and adolescent with type 1 diabetes | – | Device: nerve ultrasoundnerve ultrasound and nerve conduction study |
| healthy age matched group | – | Device: nerve ultrasoundnerve ultrasound |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nerve ultrasoundAlso: nerve conduction studynerve ultrasound | Device | diabetic children and adolescent with type 1 diabetes, healthy age matched group |
Primary outcome
cross sectional area of peripheral nerves using nerve ultrasound
Time frame: baseline
To evaluate accuracy of nerve ultrasound in detecting clinical and subclinical peripheral neuropathy in children and adolescents diagnosed with type 1 diabetes melitus .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 30079595Donaghue 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.
- Background: PubMed 20823346Charles 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.
- Background: PubMed 31083769Kallinikou 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.
- Background: PubMed 21695763Dyck 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.
- Background: PubMed 20876709Tesfaye 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.
- Background: PubMed 35949448Altuwaijri 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.
- Background: PubMed 29429781Walter-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.
- Background: PubMed 34764937Yu Y. Gold Standard for Diagnosis of DPN. Front Endocrinol (Lausanne). 2021 Oct 26;12:719356. doi: 10.3389/fendo.2021.719356. eCollection 2021.
- Background: PubMed 19893645Misra 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.
- Background: PubMed 15713353Karsidag 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.
- Background: PubMed 26905353Toopchizadeh 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.
- Background: PubMed 34109557Singh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy, run by Esraa Hosny Dahy.
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 2 inclusion and 1 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Esraa H Hosny Dahy Hassan (01064080903, esraahosny@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cross sectional area of peripheral nerves using nerve ultrasound (time frame: baseline). 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 NCT06187129, which also lists 18 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 30 Jan 2024.