A Nutritional Intervention for Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mood
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).
- Neuropathy Impairment Score for Lower Limbs (NIS-LL) The NIS-LL is the lower limb component of the full Neuropathy Impairment Score (NIS) and has 3 domains including: muscle weakness, reflexes, and sensation. The maximum score is 88 points. Based on experience with and data collected from these clinical trials, the Peripheral Nerve Society considers a 2 point change on the NIS-LL to correspond to a meaningful change in clinical status.
- Neuropathy Total Symptoms Score (NTSS-6) Neuropathy total symptom score-6 (NTSS-6) is a neuropathy sensory symptom scale that is designed to evaluate the frequency and intensity of individual neuropathy sensory symptoms identified frequently by patients with DPN. A total of six questions are synthesized to identify and quantify the specific positive and negative symptoms associated with sensory deficits in patients.
- Neuropathy Pain Scale In order to assess and differentiate qualities of pain, Galer and Jensen developed the Neuropathic Pain Scale (NPS) in 1997. The NPS is composed of 10 items that assess two global pain domains including pain intensity and unpleasantness, and six pain qualities, including sharp, hot, dull, cold, sensitive, and itchy pain, in two dimensions (internal and cutaneous).
- McGill Pain Questionnaire The McGill Pain Questionnaire (MPQ) is used to specify subjective pain experience using sensory, affective and evaluative word descriptors. The short form of the McGill Pain Questionnaire (SF-MPQ) contains 11 questions referring to the sensory dimension of the pain experience and four related to the affective dimension.
- Global Impression Scale Global impression scale (GIS) is also termed global rating of change scales (GRC) and was developed to assess patients' overall improvement or deterioration in a clinical setting, and has been frequently used in musculoskeletal and chronic pain trials.
Height. Height will be measured at baseline (only) with participants standing barefoot with their backs to a wall-mounted stadiometer and heels against the wall, recorded to the nearest 0.5 cm.
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)
结局指标
主要结局
Mood
时间窗: 20 weeks
Mood will be measured by change in score using the following assessment tools at baseline and 20 weeks: * Beck Depression Inventory * Center for Epidemiologic Studies Depression Scale Revised
Pain
时间窗: 20 weeks
Pain will be measured follow the baseline and 20 week score using n 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
Sensation
时间窗: 20 weeks
Sensation 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
Glycemic control
时间窗: 20 weeks
Glycemic control will be measured by change in hemoglobin A1c percentage points at baseline and 20 weeks.
Disease activity
时间窗: 20 weeks
Disease activity will be measured by change in small fiber density of lower limbs as measured by skin biospy done at baseline and 20 weeks.
次要结局
- Quality of life(20 weeks)