Diabetic Neuropathy Peripheral Clinical Trial
— EVANESCENT-DPNOfficial 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
Verified date | May 2024 |
Source | St. John's Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 action potential amplitude (sural and tibial nerves) at 24 weeks follow- up. - Can Nevibolol at a dose of 2.5 mg- 10 mg compared with a combination of Alpha Lipoic Acid (600 mg/day)+EPALRESTAT (150 mg/day) conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up - All potential participants will undergo screening- about 10 ml of blood will be drawn to perform the following assesments at screening- HbA1c, FBS,Vit B12, TSH, fT4. - Baseline assessments conducting a nerve conduction study, quality of life assesment using Eq-5D-5L and NRS pain score. - 20% of patients (24 patients) will undergo Sudoscan, Corneal confocal microscopy and a skin biopsy for assessing IENFD (Intra Epidermal Nerve Fibre Density). - 15th day, 1 month and 3rd month followup for evaluating patients status and medication adherance. - 6th month followup for evaluating patients status and medication adherance. Researchers will compare Nebivolol against combination of Epalrestat+Alpha Lipoic Acid against standard pain modulating treatment to evaluate their diseaes modifying effect as reflected by nerve conduction study parameters.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | March 30, 2026 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | St John's Research Institute | Bangalore | Karntakaka |
Lead Sponsor | Collaborator |
---|---|
St. John's Research Institute |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean nerve action potential amplitude (sural and tibial nerves) between Arm 1 and Arm 3 at 24 weeks follow-up. | As part of nerve conduction study, the mean nerve action potential amplitude (sural and tibial nerves) will be compared between Arm 1 and Arm 3 at 24 weeks follow-up. | Baseline and 24 weeks | |
Secondary | The proportion of patients who progress to develop severe neuropathy | To compare -
The proportion of patients who progress to severe neuropathy at week 24 follow-up. The proportion of patients having a pain numerical rating scale(NRS) score & between Nebivolol, lipoic acid+epalrestat and standard care arms at weeks 4 and 12. Quantifying the intra-epidermal nerve fibre density (IENFD), high-sensitivity C-reactive protein (hsCRP) levels and GAP-43 (neuromodulin) in a randomly selected sample (stratified by sex and baseline disease severity) of 20% patients each from the 3 arms pre and post-intervention and corneal nerve fibre length and density in all patients in the 3 arms at week 24. |
Baseline and 24 weeks |
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