Evaluating Nebivolol for Diabetic Neuropathy Treatment
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
PHASE2; PHASE3 · St. John's Research Institute · NCT06201611
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 |
| Enrollment | 120 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | St. John's Research Institute (other) |
| Locations | 2 sites (Bangalore, Karnataka and 1 other locations) |
| Trial ID | NCT06201611 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diabetes diagnosed for 5 years or less and stable glycemic control.
Not a fit: Patients with contraindications to Nebivolol or those with advanced diabetic neuropathy may not benefit from this study.
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 performed: While similar approaches have been explored, the specific use of Nebivolol in this context is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Bangalore, Karnataka and 1 other locations
- St John's Medical College Hospital — Bangalore, Karnataka, India (RECRUITING)
- St John's Research Institute — Bangalore, Karntakaka, India (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Neuropathy Peripheral