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

NCT05457192 | Unknown

• 1 other identifier: P.T.REC/012/003777
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Polyneuropathy

Keywords

Glycosylated hemoglobin; Nerve conduction studies; Diabetic polyneuropathy; Spatiotemporal gait parameters.; Type II DM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Spatiotemporal gait parameters

  At baseline for all patients

Study Arms (1)

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)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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%.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shereen Saad Eldin Mohamed Ali: lead

Study Sites (1)

Faculty of physical therapy-Cairo University

Giza, 12625, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

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

Study Officials

• Shereen Saad Eldin Mohamed, Lecturer

  lecturer of Neurology at faculty of physical therapy-Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamada Ahmed Hamada, Assistant professor

CONTACT

01117893697; hamada.ahmed@pt.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of physical therapy for Neurology

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 13, 2022
• Study Start: July 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

EG (1)