Clinical trial

Effect of Physical Activity on Neurogenesis in Peripheral Diabetic Neuropathy Type-II Diabetes

Name
RHS/EC/02-06-2023-011
Description
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.
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-12-31
Trial end
2025-03-31
Status
Not yet recruiting
Treatment
Phsical Activity
Combined Aerobic and Resistance Training
Arms:
Physical Activity (Combined Aerobic and Resistance Training)
Medication
The drug will maintain their usual activity level, foot care, diet, and blood glucose diary on a regular basis. Continue the prescribed medication
Arms:
Control Group
Size
44
Primary endpoint
Brain Derived Neurotrophic Factor (BDNF)
Baseline to after 12th Week
Nerve Growth Factor (NGF)
Baseline to after 12th Week
Vascular Endothelial Growth Factor (VEGF)
Baseline to after 12th Week
HBA1c
Baseline to after 12th Week
Nerve Conduction Study (NCS)
Baseline to after 12th Week
Berg Balance scale (BBS)
Baseline, after 4th week, after 8th week and after 12th week
Neuropathy Total Symptom Scale (NTSS-6)
Baseline, after 4th week, after 8th week and after 12th week
Dynamometry lower limb
Baseline, after 4th week, after 8th week and after 12th week
Eligibility criteria
Inclusion Criteria: * 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. * Sharp pains or cramps. * Increased sensitivity to touch * Symptoms last ≥ 6 months * HbA1c above 6.5% \<12% * Berg Balance Scale score 45-56 Exclusion Criteria: * 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 * Lower limb amputation,foot deformity or ulceration * Acute injury * Hip and Knee OA
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}
Updated at
2023-10-26

1 organization

1 product

1 indication

Product
Medication