Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities (DISNEY-T2DM)

August 27, 2024 updated by: Maria Widiastuti, Prof, Universitas Diponegoro

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type II Diabetic Mellitus without comorbidities
Patient who suffered diabetic neuropathy and history of type II diabetic mellitus without comorbidities
Diagnostic test: Electromyography
All of groups will have assessment of electromyography result
Type II Diabetic Mellitus with hypertension
Patient who suffered diabetic neuropathy and history of type II diabetic mellitus with hypertension
Diagnostic test: Electromyography
All of groups will have assessment of electromyography result
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
All of groups will have assessment of electromyography result

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
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
Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Diponegoro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Undip_Neuro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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