A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The purpose of this study is to assess whether, in individuals with diabetic neuropathy, a low-fat, vegan diet in combination with a vitamin B12 supplement improves pain, sensation and other subjective symptoms, more effectively than a vitamin B12 supplement with no diet changes. The principal measure is pain as measured by the following assessment tools: Michigan Neuropathy Screening Instrument, Norfolk Quality of Life Questionnaire, Neuropathy Impairment Score - Lower Limbs, Neuropathy Total Symptom Score, Neuropathy Pain Scale, McGill Pain Questionnaire and Global Impression Scale. The study duration is 20 weeks.
This study also examines the effects of a low-fat, vegan diet on mood, using the Center for Epidemiologic Studies Depression Scale-Revised, and the Beck Depression Inventory.
详细描述
The following determinations will be made at baseline, mid-point, and end of each 20-week study period, as well as at one-year follow up:
General status, symptoms, and medication accounting. Participants will be asked to report changes in their health and medication use.
Disease Activity. The following assessments will be used to measure pain and changes in sensory perception related to diabetic neuropathy:
Michigan Neuropathy Screening Instrument. The MNSI questionnaire consists of 15 questions followed by a single 8-point clinical examination involving inspection of the foot, assessment of ankle reflexes, and semi-quantitative determination of vibration perception.
Norfolk Quality of Life Questionnaire Norfolk QOL-DN is a 47-item questionnaire developed by the Eastern Virginia Medical School, Norfolk, VA, for assessing subjects' perception of the effects of diabetes and diabetic neuropathy. It consists of 28 items pertaining specifically to to small fiber, large fiber and autonomic nerve function symptoms, and activities of daily living (ADL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 18 - 65 years old
- •A diagnosis of type 2 diabetes
- •A diagnosis of diabetic neuropathy for at least 6 months or symptoms of diabetic neuropathy for at least 6 months
- •Score of greater than 2 on the Michigan Neuropathy Screening Instrument
- •Score of greater than 6on the Norfolk Quality of Life Questionnaire
- •Score of greater than 2 on the Neuropathy Impairment Score for Lower Limbs (NIS-LL)
- •Score of greater than 1 on the Neuropathy Total Symptom Score 6 (NTSS-6)
排除标准
- •Vitamin B12 deficiency
- •Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- •Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- •Pregnancy
- •Unstable medical or psychiatric illness
- •Likely to be disruptive in group sessions (as determined by research staff)
- •Already following a low-fat, vegan diet
- •Lack of English fluency
- •Inability to maintain current medication regimen
- •Inability or unwillingness to participate in all components of the study
- •Sensitivity to lidocaine or epinephrine (or their preservatives)
研究组 & 干预措施
Vegan diet and vitamin B12 supplement
The diet/supplement group will be asked to follow a low-fat, vegan diet for 20 weeks, and take a vitamin B12 supplement daily.
干预措施: Vegan diet and vitamin B12 supplement (Other)
Vitamin B12 supplement
The supplement group will be asked to take a daily vitamin B12 supplement, and to make no changes to their current diet.
干预措施: Vitamin B12 supplement (Dietary Supplement)
结局指标
主要结局
Pain
时间窗: 20 weeks
Pain will be measured follow the baseline and 20 week score using the following assessment tools: Michigan Neuropathy Screening Instrument Norfolk Quality of Life Questionnaire Neuropathy Impairment Score - Lower Limbs Neuropathy Total Symptom Score 6 Neuropathy Pain Scale McGill Pain Questionnaire Global Impression Scale
次要结局
- Glycemic control(20 Weeks)
- Quality of life(20 Weeks)
- Mood(20 Weeks)
- Disease activity(20 Weeks)
- Sensation(20 Weeks)