Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamins B12, B1, B2, B6, E, Mg, Zn and Palmitoylethanolamide for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve
研究概览
简要总结
To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).
详细描述
To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).
Patients - methods: In this pilot study, 61 patients with Diabetes Mellitus Type 2 (DMT2, 31 women), with mean duration of DM 17.5 years and mean age 63 years were randomly assigned, either to receive the combination of ten elements (2 tablets/24h) in the active group, (n=30), or the placebo (n=31) for 6 months. We used Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured vibration perception threshold (VPT) and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Sudomotor function was assessed with SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF). Pain (PS) questionnaire was administered, also. All patients received metformin for at least 4 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigator and examiner did not know the type of drug provided
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •on metformin therapy for at least 4 years
- •diabetes mellitus type 2 with diabetic neuropathy
- •painful neuropathy
排除标准
- •without diabetic neuropathy
研究组 & 干预措施
Active group
10-element combination tablet (n=30) Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet for 6 months
干预措施: Epineuron (Dietary Supplement)
Placebo
usual care
干预措施: Placebo group (Other)
结局指标
主要结局
Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve
时间窗: 6 months
Measurement of nerve conduction velocity with Neurometrix Diabetic Peripheral Neuropathy scan device
Michigan Screening Neuropathy Questionnaire and Examination
时间窗: 6 months
use of michigan screening questionnaire and examination
Measurement of individual Vibration Perception Threshold to study vibration perception in the feet
时间窗: 6 months
Measurement of vibration perception threshold with Biothesiometer
Measurement of electrochemical skin conductance
时间窗: 6 months
measurement with Sudoscan the electrochemical skin conductance in hands and feet
次要结局
- vitamin B12 levels(6 months)
- Glycated Hemoglobin(6 months)
研究者
Prof. Triantafyllos Didangelos
Professor of Internal Medicine and Diabetology
Aristotle University Of Thessaloniki