A Nutritional Intervention for Diabetic Neuropathy

NCT01690962 | Completed DMC

• 1 other identifier: PCRM DN-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Keywords

diabetic neuropathy, diet, vegan, vegetarian

Outcome Measures

Primary Outcomes (5)

• Pain

  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

  20 weeks

• Sensation

  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

  20 weeks

• Disease activity

  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.

  20 weeks

• Glycemic control

  Glycemic control will be measured by change in hemoglobin A1c percentage points at baseline and 20 weeks.

  20 weeks

• Mood

  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

  20 weeks

Secondary Outcomes (1)

• Quality of life

  20 weeks

Other Outcomes (1)

• Acceptability of vegan diet

  20 weeks

Study Arms (2)

Vegan diet and vitamin B12 supplement

EXPERIMENTAL

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

Vitamin B12 supplement

ACTIVE COMPARATOR

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

Interventions

Vegan diet and vitamin B12 supplement OTHER

A low-fat, vegan diet (no meat, fish, eggs or dairy products) and a vitamin B12 supplement in the form of 2000mcg of methylcobalamin

Also known as: Vegan diet

Vegan diet and vitamin B12 supplement

Vitamin B12 supplement DIETARY_SUPPLEMENT

A daily vitamin B12 supplement in the form of 2000mcg of methylcobalamin

Vitamin B12 supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Neal Barnard, MD

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 24, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

US (1)