Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change from Baseline in NTSS6 score at 3 months
研究概览
简要总结
Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. To investigate the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters of patients with metabolic neuropathies.
详细描述
Metabolic disorder such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. The objectives of the present study are to investigate:
- the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters
- the best coaching modality of education.
This will be a prospective single blind study (blinded evaluator). Patients will be randomly assigned in two groups. The first group will have a one-day therapeutic education program followed by a 5-minutes phone call every week for 3 months. The second group will have the same one-day therapeutic education program that will be followed by an unique one-hour phone call. During the one-day therapeutic education program and the phone calls, hygienic rules (ie physical activities) and dietetic regimen advices will be given to patients. Evaluation will be done at 3 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and neurophysiologic neuropathy (clinical signs of neuropathy and at least two low sensory nerve action potential (superficial peroneal and sural nerves))
- •Metabolic disorder: Glucose disorder (diabetes mellitus or glucose intolerance) or metabolic syndrome
- •Clinical signs for less than 2 years
- •No therapeutic modification in the last 3 months
- •Possibility to delay any drug modification during 3 months
排除标准
- •Non metabolic neuropathy
- •Serious diabetic complication
- •Renal failure (creatinine clearance<60ml/min)
- •Sensory neuronopathy
- •Contra-indication to physical activity
- •Type 1 diabetes mellitus
- •No written consent
研究组 & 干预措施
Coaching
active hygienic-dietetic coaching
干预措施: hygienic-dietetic measures (Behavioral)
control
reference hygienic-dietetic recommendations
干预措施: hygienic-dietetic measures (Behavioral)
结局指标
主要结局
Change from Baseline in NTSS6 score at 3 months
时间窗: 3 months
Change from Baseline in NTSS6 score at 3 months (Bastyr EJ, 3rd, Price KL, Bril V. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94)
次要结局
- clinical global impression of change(3 months)
- change from baseline of sensory nerve action potential and sensory and motor nerve velocity(3 months)
- change from baseline of thermal and vibration thresholds(3 months)
研究者
Sophie Ng Wing Tin
Investigator, clinical doctor
Henri Mondor University Hospital