A trial of potentially disease slowing medications, Nebivolol versus Epalrestat plus Lipoic Acid,.for select patients with diabetic neuropathy.

Phase 2

• Conditions: Health Condition 1: E134- Other specified diabetes mellituswith neurological complications

• Registration Number: CTRI/2024/05/068126
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified