Type II Diabetes Mellitus With Neurological ManifestationsNCT06101368
Effect of Physical Activity on Neurogenesis in Peripheral Diabetic Neuropathy Type-II Diabetes
A study testing Phsical Activity and Medication in people with Type II Diabetes Mellitus With Neurological Manifestations, run by Health Education Research Foundation (HERF).
Trial summary
Approximately 425 million people worldwide suffer from diabetes, making it a global epidemic. Diabetes consumes 12% of the global health budget, addressing the disease and its complications. In Pakistan, the estimated prevalence of diabetes stands at 9.8%, affecting both males and females. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Type II Diabetes Mellitus With Neurological Manifestations
- What is being tested?
- Phsical Activity and Medication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Mar 2025
- Phase
- Interventional
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Type-II Peripheral Diabetic Neuropathy
- Neuropathy Total Symptom Scale (NTSS-6)>6
- loss of protective sensation to detect a 10-gram Semmes Weinstein Monofilament on either foot at one of four sites tested or a vibration perception threshold value of 25V or more at either foot's hallux
- Numbness or reduced ability to feel pain or temperature changes.
- Able to Perform 20 minutes per week >2 bouts of physical activity
- Tingling or burning sensation.
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- Sharp pains or cramps.
- Increased sensitivity to touch
- Symptoms last ≥ 6 months
- HbA1c above 6.5% <12%
- Berg Balance Scale score 45-56
Who cannot join
- Patients with walking difficulty
- Retinopathy \& poor vision
- Inability to engage in activity without assistance
- Peripheral vascular disease e.g. ABI <0.6
- orthostatic hypotension, resting heart rate above 100 bpm any Cardiac Issues
- Any diagnosed neuro-psychological issue e.g. depression, dementia or anxiety
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- Lower limb amputation,foot deformity or ulceration
- Acute injury
- Hip and Knee OA
Trial locations and contacts
No sites are listed yet.
About this study
Approximately 425 million people worldwide suffer from diabetes, making it a global epidemic. Diabetes consumes 12% of the global health budget, addressing the disease and its complications. In Pakistan, the estimated prevalence of diabetes stands at 9.8%, affecting both males and females. Diabetic peripheral neuropathy is a common complaint that significantly impacts patients' quality of life. Neuropathy is prevalent in 40-55% of diabetes cases, and its incidence rises with age. Additionally, exercise can promote neurogenesis and the release of beneficial factors like BDNF, contributing to improved cognitive function and mood. Aerobic exercises are recommended for managing type 2 diabetes, while resistance training can improve glycemic control and muscle health. Further research is needed to understand the effects of physical activity on neurogenesis in diabetic peripheral neuropathy patients and gender-specific influences on glucose metabolism. The study aims to enhance peripheral neurogenesis, glycemic control, and sensory functions, ultimately improving the overall quality of life for patients.
Read the detailed description
The study design is a randomized controlled trial, and participants will be blinded to avoid interaction. A convenience sampling technique will be used, and the study will take place at Pakistan Railways Hospital and Quaid-E-Azam University. It will span two years after receiving approval. Inclusion criteria specify the type of patients eligible for the study, while exclusion criteria identify conditions that disqualify participants. Various data collection tools and tests will be used, including Neuropathy Total Symptom Scale (NTSS-6), Berg Balance Scale, HbA1c, nerve conduction studies, blood glucose level measurements, dynamometer, and questionnaires assessing quality of life.
The study procedure involves participant recruitment, randomization into treatment and control groups, baseline assessments, and a 12-week intervention for the treatment group. This includes both aerobic exercise (treadmill) and resistance training for the lower and upper extremities. Control group participants will continue their regular medication.
- Being tested
- Phsical Activity, Medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phsical ActivityBehavioural
Combined Aerobic and Resistance Training
MedicationDrug
The drug will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity (Combined Aerobic and Resistance Training) | Experimental | Group A will perform aerobic and resistance exercises at a moderate level. Brisk Walk on treadmill 5 days/week with 40-70% of Vo2max (maximal aerobic capacity) 150 min/week 50-55% humidity and a room temperature of 24-25 °C will maintain. The subject will wear insole proper fitted shoes. Aerobic exercise will be conducted for a total of 30 minutes per session for 5 days for 12 weeks. This protocol will be followed by a 10-minute warm-up and cool-down. Followed by 10-15 minutes of resistance-based exercises at a moderate intensity of three sets with 15 repetitions of upper and lower limbs respectively i.e. Dumbbell biceps curl, Standing dumbbell triceps extension, Dumbbell stiff-legged deadlifts and Dumbbell squats Resistance loads will be 40-50% of one repetition maximum. The resting interval between resistance training sets will be < 1 min. Receives: Behavioral: Phsical Activity |
| Control Group | Other | The control group will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication Receives: Drug: Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Derived Neurotrophic Factor (BDNF)
BDNF is a member of the trophic factors of nerve regeneration microenvironment and therefore involved in the regulation of nerve fiber regeneration and protection of neurons
Measured: Baseline to after 12th Week
Nerve Growth Factor (NGF)
Nerve growth factor (NGF) is a neurotrophic protein essential for the growth, differentiation, and survival of sympathetic and sensory afferent neurons during development
Measured: Baseline to after 12th Week
Vascular Endothelial Growth Factor (VEGF)
VEGF enhances nerve blood flow and oxygen supply by inducing angiogenesis, in response to nerve ischemia and hypoxia caused by Diabetic Periphral Neuropathy
Measured: Baseline to after 12th Week
HBA1c
HbA1c levels are associated with increased severity of peripheral neuropathy in patients with diabetes mellitus.
Measured: Baseline to after 12th Week
Nerve Conduction Study (NCS)
A nerve conduction study (NCS) can quantitatively detect peripheral nerve dysfunction, even in the pre-symptomatic stage of DPN onset.
Measured: Baseline to after 12th Week
Berg Balance scale (BBS)
The Berg Balance Scale (BBS) is a widely used clinical assessment tool that measures an individual's static and dynamic balance abilities. It is not specific to diabetic neuropathy but can be used to assess balance in individuals with various neurological and musculoskeletal conditions, including diabetic neuropathy.
Measured: Baseline, after 4th week, after 8th week and after 12th week
Neuropathy Total Symptom Scale (NTSS-6)
Neuropathy Total Symptom Score-6 Questionnaire (NTSS-6) is a valid instrument for assessing the positive symptoms of diabetic peripheral neuropathy (DPN). Graphic representation of pain.
Measured: Baseline, after 4th week, after 8th week and after 12th week
Dynamometry lower limb
Dynamometry is a method used to measure muscle strength, and it can be particularly useful in assessing muscle strength in the lower limbs of individuals with diabetic neuropathy.
Measured: Baseline, after 4th week, after 8th week and after 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes Mellitus With Neurological ManifestationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Danish Raouf, Health Education Research Foundation (HERF)
- Investigators
- Waqar A Awan, PhD, Principal investigator, Health Education Research FoundationRaheela Kanwal, PhD, Principal investigator, College of Applied Medical Sciences, University of Hail, Hail, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101368
- Sponsor's protocol ID
- RHS/EC/02-06-2023-011
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity on Neurogenesis in Peripheral Diabetic Neuropathy Type-II Diabetes
- ClinicalTrials.gov ID
- NCT06101368
- Acronym / sponsor ID
- RHS/EC/02-06-2023-011
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 26 Oct 2023 (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.
Approximately 425 million people worldwide suffer from diabetes, making it a global epidemic. Diabetes consumes 12% of the global health budget, addressing the disease and its complications. In Pakistan, the estimated prevalence of diabetes stands at 9.8%, affecting both males and females. Diabetic peripheral neuropathy is a common complaint that significantly impacts patients' quality of life. Neuropathy is prevalent in 40-55% of diabetes cases, and its incidence rises with age. Additionally, exercise can promote neurogenesis and the release of beneficial factors like BDNF, contributing to improved cognitive function and mood. Aerobic exercises are recommended for managing type 2 diabetes, while resistance training can improve glycemic control and muscle health. Further research is needed to understand the effects of physical activity on neurogenesis in diabetic peripheral neuropathy patients and gender-specific influences on glucose metabolism. The study aims to enhance peripheral neurogenesis, glycemic control, and sensory functions, ultimately improving the overall quality of life for patients.
Detailed description
The study design is a randomized controlled trial, and participants will be blinded to avoid interaction. A convenience sampling technique will be used, and the study will take place at Pakistan Railways Hospital and Quaid-E-Azam University. It will span two years after receiving approval. Inclusion criteria specify the type of patients eligible for the study, while exclusion criteria identify conditions that disqualify participants. Various data collection tools and tests will be used, including Neuropathy Total Symptom Scale (NTSS-6), Berg Balance Scale, HbA1c, nerve conduction studies, blood glucose level measurements, dynamometer, and questionnaires assessing quality of life.
The study procedure involves participant recruitment, randomization into treatment and control groups, baseline assessments, and a 12-week intervention for the treatment group. This includes both aerobic exercise (treadmill) and resistance training for the lower and upper extremities. Control group participants will continue their regular medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity (Combined Aerobic and Resistance Training) | Experimental | Behavioral: Phsical ActivityGroup A will perform aerobic and resistance exercises at a moderate level. Brisk Walk on treadmill 5 days/week with 40-70% of Vo2max (maximal aerobic capacity) 150 min/week 50-55% humidity and a room temperature of 24-25 °C will maintain. The subject will wear insole proper fitted shoes. Aerobic exercise will be conducted for a total of 30 minutes per session for 5 days for 12 weeks. This protocol will be followed by a 10-minute warm-up and cool-down. Followed by 10-15 minutes of resistance-based exercises at a moderate intensity of three sets with 15 repetitions of upper and lower limbs respectively i.e. Dumbbell biceps curl, Standing dumbbell triceps extension, Dumbbell stiff-legged deadlifts and Dumbbell squats Resistance loads will be 40-50% of one repetition maximum. The resting interval between resistance training sets will be < 1 min. |
| Control Group | Other | Drug: MedicationThe control group will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients with Type-II Peripheral Diabetic Neuropathy
- Neuropathy Total Symptom Scale (NTSS-6)>6
- loss of protective sensation to detect a 10-gram Semmes Weinstein Monofilament on either foot at one of four sites tested or a vibration perception threshold value of 25V or more at either foot's hallux
- Numbness or reduced ability to feel pain or temperature changes.
- Able to Perform 20 minutes per week >2 bouts of physical activity
Key exclusion criteria (9 listed)
- Patients with walking difficulty
- Retinopathy \& poor vision
- Inability to engage in activity without assistance
- Peripheral vascular disease e.g. ABI <0.6
- orthostatic hypotension, resting heart rate above 100 bpm any Cardiac Issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phsical ActivityCombined Aerobic and Resistance Training | Behavioural | Physical Activity (Combined Aerobic and Resistance Training) |
| MedicationThe drug will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication | Drug | Control Group |
Primary outcome
Brain Derived Neurotrophic Factor (BDNF)
Time frame: Baseline to after 12th Week
BDNF is a member of the trophic factors of nerve regeneration microenvironment and therefore involved in the regulation of nerve fiber regeneration and protection of neurons
Nerve Growth Factor (NGF)
Time frame: Baseline to after 12th Week
Nerve growth factor (NGF) is a neurotrophic protein essential for the growth, differentiation, and survival of sympathetic and sensory afferent neurons during development
Vascular Endothelial Growth Factor (VEGF)
Time frame: Baseline to after 12th Week
VEGF enhances nerve blood flow and oxygen supply by inducing angiogenesis, in response to nerve ischemia and hypoxia caused by Diabetic Periphral Neuropathy
HBA1c
Time frame: Baseline to after 12th Week
HbA1c levels are associated with increased severity of peripheral neuropathy in patients with diabetes mellitus.
Nerve Conduction Study (NCS)
Time frame: Baseline to after 12th Week
A nerve conduction study (NCS) can quantitatively detect peripheral nerve dysfunction, even in the pre-symptomatic stage of DPN onset.
Berg Balance scale (BBS)
Time frame: Baseline, after 4th week, after 8th week and after 12th week
The Berg Balance Scale (BBS) is a widely used clinical assessment tool that measures an individual's static and dynamic balance abilities. It is not specific to diabetic neuropathy but can be used to assess balance in individuals with various neurological and musculoskeletal conditions, including diabetic neuropathy.
Neuropathy Total Symptom Scale (NTSS-6)
Time frame: Baseline, after 4th week, after 8th week and after 12th week
Neuropathy Total Symptom Score-6 Questionnaire (NTSS-6) is a valid instrument for assessing the positive symptoms of diabetic peripheral neuropathy (DPN). Graphic representation of pain.
Dynamometry lower limb
Time frame: Baseline, after 4th week, after 8th week and after 12th week
Dynamometry is a method used to measure muscle strength, and it can be particularly useful in assessing muscle strength in the lower limbs of individuals with diabetic neuropathy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Waqar A Awan, PhD principal investigator
Health Education Research Foundation
Raheela Kanwal, PhD principal investigator
College of Applied Medical Sciences, University of Hail, Hail, Saudi Arabia
Questions about this trial
What is this clinical trial studying?
A study testing Phsical Activity and Medication in people with Type II Diabetes Mellitus With Neurological Manifestations, run by Health Education Research Foundation (HERF).
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 11 inclusion and 9 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Waqar Ahmed Awan, PhD (+923335348846, wawan01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Derived Neurotrophic Factor (BDNF) (time frame: Baseline to after 12th Week). The study lists 8 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 26 Oct 2023.