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

NCT06573684 | Completed

• 1 other identifier: Undip_Neuro
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Neuropathies

Keywords

Type II diabetic mellitus; Diabetic neuropathy; Electromyography

Outcome Measures

Primary Outcomes (1)

• Distal Latency

  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 Outcomes (2)

• Nerve Conduction Velocity

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

• Amplitude

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

Study Arms (3)

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

Electromyography DIAGNOSTIC_TEST

All of groups will have assessment of electromyography result

Type II Diabetic Mellitus with hypertension; Type II Diabetic Mellitus with hypertension and dyslipidemia; Type II Diabetic Mellitus without comorbidities

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (1)

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 33194943 BACKGROUND

• 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.

  PMID: 15668414 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)