Diabetic PolyneuropathyNCT05457192
Correlation of HbA1c With Electrophysiological Studies and Gait Performance in Diabetic Polyneuropathy Patients
An observational study of Diabetic Polyneuropathy, run by Shereen Saad Eldin Mohamed Ali at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetic Polyneuropathy
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2022to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
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%.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy-Cairo University
Giza, 12625
Hamada Ahmed Hamada, assistant professor, 01117893697 ext. 002, hamada.ahmed@pt.cu.edu.eg
About this study
Official title: 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).
Read the 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).
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Glycosylated hemoglobin, Nerve conduction studies, Diabetic polyneuropathy, Spatiotemporal gait parameters., Type II DM
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At baseline for all patients
Secondary outcomes (1)
Spatiotemporal gait parameters
Spatiotemporal gait parameters for all the patients will be assessed by two-dimension video-based motion analysis (2D).
Measured: At baseline for all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shereen Saad Eldin Mohamed Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shereen Saad Eldin Mohamed Ali, Cairo University
- Investigators
- Shereen Saad Eldin Mohamed, Lecturer, Principal investigator, lecturer of Neurology at faculty of physical therapy-Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457192
- Sponsor's protocol ID
- P.T.REC/012/003777
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycosylated Hemoglobin and Its Correlations With Electrophysiological Studies and Gait Performance in Diabetic Polyneuropathy Patients
- ClinicalTrials.gov ID
- NCT05457192
- Acronym / sponsor ID
- P.T.REC/012/003777
- Conditions
- Diabetic Polyneuropathy
- Keywords
- Glycosylated hemoglobin, Nerve conduction studies, Diabetic polyneuropathy, Spatiotemporal gait parameters., Type II DM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Shereen Saad Eldin Mohamed AliUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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%.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients with type I DM.
- History of myopathy or neuromuscular diseases.
- Pregnant females.
- Alcoholics.
- History of major cardiac diseases, heavy metal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The neurophysiological parameters
Time frame: At baseline for all patients
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.
Glycosylated Hemoglobin (HbA1c) level
Time frame: At baseline for all patients
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
1 secondary outcome
Spatiotemporal gait parameters
Time frame: At baseline for all patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
Related trials for Diabetic Polyneuropathy
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Active, not recruitingObservational study
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy
RecruitingPhase 2
Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy
Diabetic Polyneuropathy
Not yet recruitingObservational study
Is Serum Irisin Level a Biomarker in Diabetic Polyneuropathy?
Polyneuropathies, Diabetic Complications Neurological
Recruiting
Normast3 for Adults With Diabetic Polyneuropathy
Diabete Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shereen Saad Eldin Mohamed, Lecturer principal investigator
lecturer of Neurology at faculty of physical therapy-Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Polyneuropathy, run by Shereen Saad Eldin Mohamed Ali at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamada Ahmed Hamada, Assistant professor (01117893697 ext. 002, hamada.ahmed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The neurophysiological parameters (time frame: At baseline for all patients). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.