A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)

Completed · Not applicable

Conditions studied: Diabetic Neuropathy

In brief

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.

Key facts

Study ID

NCT01953757

Run by

Physicians Committee for Responsible Medicine

People needed

20

Starts

2013-09-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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)

Where it is running

• Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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