Evaluating Nebivolol for Diabetic Neuropathy Treatment
Official title: A 3-arm, Open-label, Stratified Randomized Controlled Trial With Blinded End-point Assessment to EValuate A Nitric oxidE Generator (Nebivolol) as a diSease Modifying mediCatioN in Diabetic Peripheral Neuropathy
Run by St. John's Research Institute · NCT06201611 · Data updated 2026-11-12
This study is testing if a medication called Nebivolol can help people with diabetic neuropathy feel better compared to other treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | St. John's Research Institute Academic / other |
| Locations | 2 sites (Bangalore, Karnataka and 1 other locations) |
| Status | Recruiting |
| Started | November 15, 2024 |
| Main results expected | December 30, 2025 |
| Study ends | March 30, 2026 |
| Registry record updated | February 4, 2025 |
| Trial ID | NCT06201611 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with diabetes diagnosed for 5 years or less and stable glycemic control.
✕Probably not a fit
Patients with contraindications to Nebivolol or those with advanced diabetic neuropathy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness of Nebivolol, a nitric oxide generator, in patients with diabetic neuropathy. Participants will be randomly assigned to receive either Nebivolol, a combination of Alpha Lipoic Acid and Epalrestat, or standard care alone. The primary focus is to measure the mean nerve action potential amplitude at 24 weeks, comparing the different treatment arms. Additional assessments will include nerve fiber density and inflammatory markers to evaluate the broader impact of the treatment.
Why it matters
Potential benefit: If successful, this treatment could improve nerve function and quality of life for patients suffering from diabetic neuropathy.
How similar studies have gone: While similar approaches have been explored, the specific use of Nebivolol in this context is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged \>= 18 years diagnosed with diabetes mellitus, of a duration of \<= 5 years since their diagnosis 2. HbA1c \< 9 at enrolment with stable glycemic control for the last three months 3. Neuropathy meeting the following 'Toronto criteria' (8) - (a) abnormal nerve conduction study\* based on age-matched controls at the site and - (b) a symptom or sign of neuropathy defined as one of either a diabetic neuropathy symptom score of \>= 1/4 Or neuropathy disability score of \>= 3/10 (9). * Abnormal NCS defined as one or more abnormal Z score in two or more nerves, based on sural nerve amplitude (antidromic stimulation), tibial and peroneal NCV, tibial amplitude, increased F-wave minimum latency (F-min), and absent F-waves (only considered abnormal in tibial nerve) Exclusion Criteria: 1. Absolute contra-indications for nebivolol - sick-sinus syndrome, sinus bradycardia with a resting heart rate \< 50/ minute, second or third degree AV-nodal blocks fascicular blocks, severe asthma or COPD and acute heart failure 2. Patients with a compelling indication for a non-dihydropyridine calcium channel blocker (CCB) 3. Patients with compelling need for another beta-blocker in the judgement of the treating team Patients who have undergone major amputations of the lower limbs or are posted for the same.
Where it's running
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St John's Medical College Hospital
Bangalore, Karnataka, India Recruiting -
St John's Research Institute
Bangalore, Karntakaka, India Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adding proprioceptive neuromuscular facilitation to Otago exercises to reduce fall risk in people with type 2 diabetes
This tests whether adding PNF to standard Otago balance and strength exercises helps people aged 50–75 with type 2 diabetes and peripheral neuropathy reduce their risk of falling.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.