Efficacy and safety of the daily oral supplementation of fish oil with high-dose docosahexaenoic acid content and cobalamin in patients with painful diabetic neuropathy

Tabriz University of Medical Sciences0 个研究点目标入组 86 人开始时间: 待定最近更新: 2023年11月13日

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•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

•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

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