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OpenTrials
Completed

NCT Number: NCT06573684

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Electromyography

Diagnostic Test

All of groups will have assessment of electromyography result

Primary outcomes

  1. Distal Latency

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

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

Secondary outcomes

  1. Nerve Conduction Velocity

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

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

  2. Amplitude

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

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

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Acronym: DISNEY-T2DM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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