Correlation of HbA1c With Electrophysiological Studies and Gait Performance in Diabetic Polyneuropathy Patients

Glycosylated Hemoglobin and Its Correlations With Electrophysiological Studies and Gait Performance in Diabetic Polyneuropathy Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetic Polyneuropathy

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).

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

• Study Contact: Name: Hamada Ahmed Hamada, assistant professor; Phone Number: 002 01117893697; Email: hamada.ahmed@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12625
    • Recruiting
    • Faculty of Physical Therapy-Cairo University
    • Contact: Hamada Ahmed Hamada, assistant professor; Phone Number: 002 01117893697; Email: hamada.ahmed@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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%.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Moderate diabetic polyneuropathy (DPN); 65 patients of both sexes (males & females) with type II DM with moderate polyneuropathy will be included. Patients will be enrolled and assessed for their eligibility to participate in this study. 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%. All the patients suffering from moderate polyneuropathy according to Toronto Clinical Neuropathy Scoring System (TCSS) (score nine to 11 points), and Neuropathy Impairment Score in the lower limbs (NIS-LL) (The muscle power of the lower limbs will be more than grade 2 and less than grade 4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The neurophysiological parameters	Five nerves will be examined in this study including (The common peroneal, tibial, sural and ulnar motor & sensory branches). Nerve conduction studies (NCS) will be performed by using the electromyography device.	At baseline for all patients
Glycosylated Hemoglobin (HbA1c) level	Glycosylated Hemoglobin (HbA1c) test will be done for each patient by using the Colorimeter device. The Blood will be collected in a EDTA (3 cm) tube	At baseline for all patients

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatiotemporal gait parameters	Spatiotemporal gait parameters for all the patients will be assessed by two-dimension video-based motion analysis (2D).	At baseline for all patients

Collaborators and Investigators

• Sponsor: Shereen Saad Eldin Mohamed Ali
• Investigators: Principal Investigator: Shereen Saad Eldin Mohamed, Lecturer, lecturer of Neurology at faculty of physical therapy-Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Nerve conduction studies; Diabetic polyneuropathy; Glycosylated hemoglobin; Spatiotemporal gait parameters.; Type II DM
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies
• Other Study ID Numbers: P.T.REC/012/003777

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No