Clinical trial NCT06573684: Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities
Official title: Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathies
Keywords: Type II diabetic mellitus
Diabetic neuropathy
Electromyography
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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. 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.


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:

* 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

Primary outcomes:
measure: Distal Latency
timeFrame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Secondary outcomes:
measure: Nerve Conduction Velocity
timeFrame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
measure: Amplitude
timeFrame: Electromyography examination was done approximately 1 year after clinical onset of neuropathy appear
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi Central General Hospital
state: Central Of Java
Study officials:
References:
citation: 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.
citation: 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.