Clinical trial NCT06101368: Effect of Physical Activity on Neurogenesis in Peripheral Diabetic Neuropathy Type-II Diabetes
Official title: Effect of Physical Activity on Neurogenesis in Peripheral Diabetic Neuropathy Type-II Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type II Diabetes Mellitus With Neurological Manifestations
Lead sponsor: Health Education Research Foundation (HERF)
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

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

Primary outcomes:
measure: Brain Derived Neurotrophic Factor (BDNF)
timeFrame: Baseline to after 12th Week
measure: Nerve Growth Factor (NGF)
timeFrame: Baseline to after 12th Week
measure: Vascular Endothelial Growth Factor (VEGF)
timeFrame: Baseline to after 12th Week
measure: HBA1c
timeFrame: Baseline to after 12th Week
measure: Nerve Conduction Study (NCS)
timeFrame: Baseline to after 12th Week
measure: Berg Balance scale (BBS)
timeFrame: Baseline, after 4th week, after 8th week and after 12th week
measure: Neuropathy Total Symptom Scale (NTSS-6)
timeFrame: Baseline, after 4th week, after 8th week and after 12th week
measure: Dynamometry lower limb
timeFrame: Baseline, after 4th week, after 8th week and after 12th week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Health Education Research Foundation
name: Waqar A Awan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Applied Medical Sciences, University of Hail, Hail, Saudi Arabia
name: Raheela Kanwal, PhD
role: PRINCIPAL_INVESTIGATOR
References: