A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)

This study is currently recruiting participants.
Verified October 2013 by Physicians Committee for Responsible Medicine
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01953757
First received: September 26, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Diabetic Neuropathy
Other: Vegan diet and vitamin B12 supplement
Dietary Supplement: Vitamin B12 supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)

Resource links provided by NLM:


Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • Pain [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Sensation [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Disease activity will be measured by change in galvanic skin response, as measured by Sudoscan technology. Galvanic skin response detects sweat gland function, which is an indicator of small nerve fiber function..

  • Glycemic control [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    Glycemic control will be measured by change in hemoglobin A1c percentage points at baseline and 20 weeks.

  • Mood [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]

    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


  • Quality of life [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]

    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



Other Outcome Measures:
  • Acceptability of vegan diet [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
    Acceptability of vegan diet will be measured by change in score at baseline and 20 weeks using the Eating Inventory questionnaire.


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Vegan diet and vitamin B12 supplement
A low-fat, vegan diet (no meat, fish, eggs or dairy products) and a vitamin B12 supplement in the form of 2000mcg of methylcobalamin
Other Name: Vegan diet
Active Comparator: 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.
Dietary Supplement: Vitamin B12 supplement
A daily vitamin B12 supplement in the form of 2000mcg of methylcobalamin
Other Name: B12

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953757

Contacts
Contact: Neal Barnard, MD 202-686-2210 ext 303 nbarnard@pcrm.org
Contact: Anne Bunner, PhD 202-686-2210 ext 379 abunner@pcrm.org

Locations
United States, District of Columbia
Physicians Committee for Responsible Medicine Recruiting
Washington, District of Columbia, United States, 20016
Contact: Neal Barnard, MD    202-686-2210 ext 303    nbarnard@pcrm.org   
Contact: Anne Bunner, PhD    202-686-2210 ext 379    abunner@pcrm.org   
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Neal Barnard, MD Physicians Committee for Responsible Medicine
  More Information

No publications provided

Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01953757     History of Changes
Other Study ID Numbers: PCRM DN-2
Study First Received: September 26, 2013
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Physicians Committee for Responsible Medicine:
diabetic neuropathy, diet, vegan, vegetarian

Additional relevant MeSH terms:
Diabetic Neuropathies
Food Habits
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Habits
Signs and Symptoms
Poisoning
Substance-Related Disorders
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014