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CompletedNCT06573684DISNEY-T2DMUpdated Aug 29, 2024

Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities

An observational study in Diabetic Neuropathies, sponsored by Universitas Diponegoro. Completed at 1 site in Indonesia. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by Universitas Diponegoro · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
78
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn the differences severity level of diabetic neuropathy based on electromyelography in type II diabetic patient with and without comorbidities. The main questions of this study:

  1. What is the electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
  2. Is there any differences in electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
  3. Is there any association between distal latency with nerve conduction velocity in type II diabetic patient with and without comorbidities?
  4. Is there any association between distal latency with amplitude in type II diabetic patient with and without comorbidities?
  5. Is there any differences on diabetic neuropathy severity based on age, height, and A1C levels in type II diabetic patient with and without comorbidities?

Researchers will collect information based on hospital registry as secondary data of in type II diabetic patient with and without comorbidities. The data consist of demographic data, clinical presentation, laboratory, and electromyography were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.

02

Conditions studied

  • Diabetic Neuropathies

Keywords

  • Type II diabetic mellitus
  • Diabetic neuropathy
  • Electromyography
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 78 is below the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Universitas Diponegoro is the lead sponsor of 23 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patient with type II diabetic mellitus who suffered diabetic neuropathy which diagnosed by using electromyography and fulfill the eligibility criteria

Inclusion criteria

  • Diabetic neuropathy patient who classified as distal symmetrical polyneuropathy
  • Diabetic neuropathy patient who has no comorbidities
  • Diabetic neuropathy patient who has hypertension
  • Diabetic neuropathy patient who has hypertension and dyslipidemia

Exclusion criteria

Exclusion Criteria:

  • Diabetic neuropathy patient with history of chemotherapy
  • Diabetic neuropathy patient with history of hernia nucleus pulposus
  • Diabetic neuropathy patient with history of CKD stage V or on routine dyalisis
  • Missing data on medical record
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
78 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Type II Diabetic Mellitus without comorbidities

    Patient who suffered diabetic neuropathy and history of type II diabetic mellitus without comorbidities

    Diagnostic Test: Electromyography

  • Type II Diabetic Mellitus with hypertension

    Patient who suffered diabetic neuropathy and history of type II diabetic mellitus with hypertension

    Diagnostic Test: Electromyography

  • Type II Diabetic Mellitus with hypertension and dyslipidemia

    Patient who suffered diabetic neuropathy and history of type II diabetic mellitus with hypertension and dyslipidemia

    Diagnostic Test: Electromyography

Interventions

  • Diagnostic testElectromyography

    All of groups will have assessment of electromyography result

06

What researchers measure

Primary outcomes

  1. Distal Latency

    Distal latency defined as time between stimuli until deflection of Compound Muscle Action Potentials (CMAP) from baseline

    Time frame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear

Secondary outcomes

  1. Nerve Conduction Velocity

    Nerve Conduction Velocity defined as the measurement of axon conduction velocity by dividing space of nerve conduction with time needed

    Time frame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear

  2. Amplitude

    Amplitude define as the height of first negative deflection of Compound Muscle Action Potentials (CMAP) from baseline

    Time frame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear

07

Study locations

1 site
  • Dr. Kariadi Central General Hospital
    Semarang, Central Of Java, Indonesia
08

References and documents

Publications

  • Lu Y, Xing P, Cai X, Luo D, Li R, Lloyd C, Sartorius N, Li M. Prevalence and Risk Factors for Diabetic Peripheral Neuropathy in Type 2 Diabetic Patients From 14 Countries: Estimates of the INTERPRET-DD Study. Front Public Health. 2020 Oct 20;8:534372. doi: 10.3389/fpubh.2020.534372. eCollection 2020. PubMed 33194943 ↗
  • England JD, Gronseth GS, Franklin G, Miller RG, Asbury AK, Carter GT, Cohen JA, Fisher MA, Howard JF, Kinsella LJ, Latov N, Lewis RA, Low PA, Sumner AJ; American Academy of Neurology; American Association of Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Distal symmetric polyneuropathy: a definition for clinical research: report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2005 Jan 25;64(2):199-207. doi: 10.1212/01.WNL.0000149522.32823.EA. PubMed 15668414 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06573684
Lead sponsor
Universitas Diponegoro
Responsible party
Maria Widiastuti, Prof (Professor, Universitas Diponegoro) — Principal investigator
First posted
Aug 27, 2024
Start date
Jan 1, 2024
Primary completion
Jun 30, 2024
Completion
Aug 1, 2024
Last update
Aug 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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