Concurrent Training vs Soleus Push-Ups on Neurogenesis-Related Biomarkers in Diabetic Neuropathy … (NCT07675720) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Concurrent Training vs Soleus Push-Ups on Neurogenesis-Related Biomarkers in Diabetic Neuropathy Patients
Pakistan99 participantsStarted 2026-09
Plain-language summary
This study will examine how two types of exercise programs affect nerve health in people with diabetic peripheral neuropathy. Diabetic peripheral neuropathy is a common complication of type 2 diabetes that can cause numbness, pain, balance problems, and reduced quality of life. Exercise is often recommended for people with diabetes, but it is not yet clear which types of exercise are most effective for improving nerve function.
In this randomized controlled trial, participants with type 2 diabetes and confirmed peripheral neuropathy will be assigned to one of three groups. One group will perform a combined program of aerobic and resistance exercises (concurrent training). Another group will perform soleus push-up exercises, a seated ankle movement designed to activate the soleus muscle and improve glucose metabolism. The third group will continue with standard diabetes care and general lifestyle advice without a structured exercise program.
The study will evaluate whether these exercise interventions influence biological markers related to nerve repair and neuroplasticity, including brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), and the Schwann cell marker S100B. In addition, the study will assess changes in neuropathy symptoms, balance and postural stability, blood sugar control, and quality of life.
Participants will complete assessments before the intervention and again during follow-up after the exercise program. The findings of this study may help identify effective and feasible exercise strategies to support nerve health, improve physical function, and reduce the impact of diabetic peripheral neuropathy.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 40-65 years
* Diagnosed Type 2 Diabetes Mellitus (T2DM) Confirmed diagnosis of T2DM for at least 5 years.
* Confirmed Diabetic Peripheral Neuropathy (DPN)
Diagnosis is based on clinical evaluation and scoring tools such as:
* Michigan Neuropathy Screening Instrument (MNSI) Cut-off value of ≥4 for Part A (History)(104) Cut-off value of ≥2 from Part B (Examination)(105)
* Vibration Pressure Threshold (≥25 Volts)(106)
* HbA1c between 6.5% and 9.0% Reflecting moderate glycemic control, patients with extremely poor control were excluded for safety.
* Stable medication regimen No changes in antidiabetic, antihypertensive, or neuropathy medications in the past 3 months.
* Sedentary or low physical activity level Based on standard questionnaires (International Physical Activity Questionnaire - IPAQ), not currently engaged in structured exercise programs.
* Ability to walk independently To ensure safety during aerobic or resistance exercise (for Group A).
* Able to understand and follow instructions
* Consent to participate and comply with study protocol
* Written informed consent, obtained before randomization
Exclusion Criteria:
* History of recent cardiovascular events Includes myocardial infarction, stroke, or any cardiac intervention within the past 6 months.
* Uncontrolled hypertension Blood pressure ≥160/100 mmHg at rest.
* Severe musculoskeletal disorders or physical disability Including joint deformities, fractures, or amputa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
BDNF (Brain-Derived Neurotrophic Factor)
Timeframe: From enrollment to 4 weeks and then to the end of treatment at 8 weeks.
2
NGF (Nerve Growth Factor)
Timeframe: From enrollement to 4 weeks and then after 8 weeks of intervention
3
S100B (Schwann Cell Marker)
Timeframe: From enrollment to 4 weeks and then after 8 weeks of intervention