Clinical Trial: A Nutritional Intervention for Diabetic Neuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Nutritional Intervention for Diabetic Neuropathy

Brief Summary:

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.


Detailed Summary:

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 a
    Sponsor: Physicians Committee for Responsible Medicine

    Current Primary Outcome:

    • Pain [ Time Frame: 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 [ Time Frame: 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
    • Disease activity [ Time Frame: 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.
    • Glycemic control [ Time Frame: 20 weeks ]
      Glycemic control will be measured by change in hemoglobin A1c percentage points at ba

      Original Primary Outcome:

      • Pain [ Time Frame: 20 weeks ]
      • Sensation [ Time Frame: 20 weeks ]
      • Disease activity [ Time Frame: 20 weeks ]
      • Glycemic control [ Time Frame: 20 weeks ]
      • Mood [ Time Frame: 20 weeks ]


      Current Secondary Outcome: Quality of life [ Time Frame: 20 weeks ]

      Quality of Life will be measured by change in score using the following assessment tools at baseline and 20 weeks:

      • Norfolk Quality of Life Questionnaire
      • MOS SF-36 Questionnaire


      Original Secondary Outcome: Quality of life [ Time Frame: 20 weeks ]

      Information By: Physicians Committee for Responsible Medicine

      Dates:
      Date Received: September 17, 2012
      Date Started: November 2012
      Date Completion:
      Last Updated: September 2, 2014
      Last Verified: September 2014