Docosahexaenoic acid and cobalamin in diabetic neuropathy

Phase 3

• Conditions: Diabetic Neuropathy.; Polyneuropathy in diseases classified elsewhere; G63.2

• Registration Number: IRCT20161022030424N9
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Age of 45 and above
Having diabetes based on WHO criteria (random plasma glucose =11·1 mmol/L, fasting plasma glucose =7·0 mmol/L, or 2-hour plasma glucose =11·1 mmol/L with oral glucose tolerance test) and based on the patient's record that has been in STABLE condition for at least three months (STABLE hypoglycemic drugs without insulin change +_20% and glycosylated hemoglobin [HbA1c] <9% at screening)
Regular attendance at the hospital's outpatient clinic to ensure monitoring of blood sugar control and diabetes complications
Documented clinical diagnosis of distal neuropathic pain based on pre-established criteria for peripheral neuropathy, neurological examination and EMG/NCV confirmed
Experiencing neuropathic pain by scoring more than four in the Pain Diagnostic Questionnaire (DN4) or scoring more than 12 in the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S -LANSS) for at least three months

Exclusion Criteria

Clinical evidence of severe or acute cardiovascular disease (heart attack or stroke in the past year)
Atrial fibrillation or other cardiac arrhythmias
Renal disease
Cerebrovascular disease and any other systemic disease
Allergy to omega-3 supplements or fish

Study & Design

• Study Type: interventional
• Study Design: Not specified