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

NCT ID: NCT06573684

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Neuropathies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type II Diabetic Mellitus without comorbidities

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

All of groups will have assessment of electromyography result

Interventions

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Electromyography

All of groups will have assessment of electromyography result

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitas Diponegoro

OTHER

Sponsor Role lead

Responsible Party

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Maria Widiastuti, Prof

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 33194943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15668414 (View on PubMed)

Other Identifiers

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Undip_Neuro

Identifier Type: -

Identifier Source: org_study_id

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