Health Condition 1: E134- Other specified diabetes mellituswith neurological complications
Conditions
Interventions
Intervention1: Tab.Nebivolol: 2.5 mg/day from baseline to week 2, up-titrated to 5 mg/day at week 2 and from 5 mg/ day to 10 mg/day from week 4 to week 24 after an ECG at week 4 plus standard care pai
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged above 18 years diagnosed with diabetes mellitus, of a duration of more than 5 years since their diagnosis 2. HbA1c greater than 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 more than 1/4 Or neuropathy disability score of more than 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
Exclusion criteria: 1. Absolute contra-indications for nebivolol sick-sinus syndrome, sinus bradycardia with a resting heart rate above 50 beats per 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 judgment of the treating team Patients who have undergone major amputations of the lower limbs or are posted for the same.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean nerve action potential amplitude (sural and tibial nerves) between Arm 1 and Arm 3 at 24 weeks follow-up.Timepoint: The mean nerve action potential amplitude (sural and tibial nerves) between Arm 1 and Arm 3 at 24 weeks follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare 1 Proportion of patients who progress to severe neuropathy at week 24 follow up 2 Proportion of patients having a pain numerical rating scale score above 3 between Nebivolol, lipoic acid epalrestat & standard care arms at weeks 4 and 12 3 Quantifying the intraepidermal nerve fibre density IENFD, high sensitivity C reactive protein hsCRP levels and GAP43 neuromodulin in a randomly selected sample stratified by sex and baseline disease severity of 20 percent patients each from the 3 arms pre and post intervention 4 Electrical conductance mean mu Siemens using Sudoscan 10 between the nebivolol arm versus standard care alone and the nebivolol arm versus alphalipoic acid plus epalrestat arm at week 24 5 Mean nerve conduction velocity, latency duration Nebivolol versus standard care and nebivolol versus alpha lipoic acid epalrestat arms at week 24 Timepoint: At 4, 12 and 24 weeks different criteria will be followed up | — |
Countries
India
Contacts
Public ContactDr Deepak Kamath
St, Johns Medical College Hospital
Outcome results
None listed