Clinical trial NCT05457192: Correlation of HbA1c With Electrophysiological Studies and Gait Performance in Diabetic Polyneuropathy Patients
Official title: Glycosylated Hemoglobin and Its Correlations With Electrophysiological Studies and Gait Performance in Diabetic Polyneuropathy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Polyneuropathy
Keywords: Glycosylated hemoglobin
Nerve conduction studies
Diabetic polyneuropathy
Spatiotemporal gait parameters.
Type II DM
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include 65 Egyptian patients with type II DM with moderate polyneuropathy. Both sex (males \& females) will be included. The patients will be recruited from the Out- patient clinic of Faculty of Physical Therapy, Cairo University. Their body mass index (BMI) will range from 20:30 kg/m2, age will range from 40-60 years, postprandial blood sugar more than 200 mg/dl, duration of diabetic illness five years ago or more and serum Hb1AC will be between 7% and 14%.

Brief summary: This study will be conducted to investigate the relationship between glycosylated hemoglobin (HbA1c) and nerve conduction studies (NCS) with gait performance in patients with DPN. 65 patients with type II DM with moderate polyneuropathy will participate in this study. Glycosylated Hemoglobin (HbA1c) test will be done for each patient by using the Colorimeter device. Nerve conduction studies (NCS) will be performed for each patient by using the electromyography device to confirm the diagnosis of DPN. The neurophysiological functions of peripheral nerves including (The Common peroneal, Tibial, Sural, and Ulnar motor \& sensory branches) will be measured. Spatiotemporal gait parameters (stride length, cadence\& velocity) for all the patients will be assessed by two-dimension video-based motion analysis (2D).

Detailed description: The current study is to investigate the correlation between glycosylated haemoglobin (HbA1c) with nerve conduction studies (NCS) including amplitudes, conduction velocities \&latency with spatiotemporal gait parameters including stride length, cadence\& velocity in patients with diabetic polyneuropathy (DPN). The patients will be recruited from the Out- patient clinic of Faculty of Physical Therapy, Cairo University. All the patients suffering from moderate polyneuropathy according to Toronto Clinical Neuropathy Scoring System (TCSS), and Neuropathy Impairment Score in the lower limbs (NIS-LL). Glycosylated Hemoglobin (HbA1c) test will be done for each patient by using the Colorimeter device. Blood will be collected in a EDTA (3 cm) tube that's attached to the needle. A nerve conduction study will be performed for each patient. Five nerves will be examined in this study including (The common peroneal, tibial, sural and ulnar motor \& sensory branches). The Nerve conduction studies involve analysis of specific parameters including amplitude (mv), latency (msec.) and conduction velocity(m/s). The evaluation procedure will be explained to each patient before starting examination. Gait parameters including (stride length, cadence \& velocity) will be assessed using 2D video-based motion analysis. The gait will be captured by a digital video camera; (Canon 10 mega pixel - 4x optical zoom, lens 4x15/6.2-24.8mm1:2.7-5.6). The resultant captured film will then be processed using a special software computer program (Adobe premier ver. 6.0).

Eligibility criteria: Inclusion Criteria:

* The diagnosis will be confirmed by Nerve Conduction Studies "NCS".
* All the patients suffering from moderate polyneuropathy according to Toronto Clinical Neuropathy Scoring System (TCSS) and Neuropathy Impairment Score (NIS-LL).
* Body mass index (BMI) will range from 20:30 kg/m2.
* Age will range from 40-60 years.
* Postprandial blood sugar more than 200 mg/dl.
* Duration of diabetic illness five years ago or more and serum Hb1AC will be between 7% and 14%.
* Able to walk independently with or without walking aids.

Exclusion Criteria:

* Patients with type I DM.
* History of myopathy or neuromuscular diseases.
* Pregnant females.
* Alcoholics.
* History of major cardiac diseases, heavy metal.
* Other neurological problems as stroke.
* History of ulcers in the lower limbs, foot deformities or malunion fracture of the lower limbs, and acute nerve root compression or advanced arthritis affecting lower extremity.

Primary outcomes:
measure: The neurophysiological parameters
timeFrame: At baseline for all patients
measure: Glycosylated Hemoglobin (HbA1c) level
timeFrame: At baseline for all patients
Secondary outcomes:
measure: Spatiotemporal gait parameters
timeFrame: At baseline for all patients
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy-Cairo University
Study officials:
affiliation: lecturer of Neurology at faculty of physical therapy-Cairo university
name: Shereen Saad Eldin Mohamed, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: