Status:
RECRUITING
Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.
Lead Sponsor:
St. John's Research Institute
Conditions:
Diabetic Neuropathy Peripheral
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to test in patients with diabetic neuropathy, * Can Nevibolol at a dose of 2.5 mg- 10 mg compared with standard pain modulating treatment conserve the mean nerve ac...
Detailed Description
A 3 centre, 3-arm, parallel group, open label, stratified randomized controlled trial design is used with a 1:1:1 allocation ratio and blinding of outcome assessors. Primary Objectives: 1. To evalua...
Eligibility Criteria
Inclusion
- Patients aged \>= 18 years diagnosed with diabetes mellitus, of a duration of \<= 5 years since their diagnosis
- HbA1c \< 9 at enrolment with stable glycemic control for the last three months
- 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
- 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
- Patients with a compelling indication for a non-dihydropyridine calcium channel blocker (CCB)
- 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.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06201611
Start Date
November 15 2024
End Date
March 30 2026
Last Update
February 4 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
St John's Medical College Hospital
Bangalore, Karnataka, India, 560034
2
St John's Research Institute
Bangalore, Karntakaka, India, 560034