A Nutritional Intervention for Diabetic Neuropathy
This study is ongoing, but not recruiting participants.
Sponsor:
Physicians Committee for Responsible Medicine
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01690962
First received: September 17, 2012
Last updated: February 7, 2013
Last verified: February 2013
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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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
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 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 ] [ 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 small fiber density of lower limbs as measured by skin biospy done at baseline and 20 weeks.
- 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
Secondary Outcome Measures:
- 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: | November 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (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
|
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: NCT01690962
Locations
| United States, District of Columbia | |
| Physicians Committee for Responsible Medicine | |
| Washington, District of Columbia, United States, 20016 | |
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: | NCT01690962 History of Changes |
| Other Study ID Numbers: | PCRM DN-1 |
| Study First Received: | September 17, 2012 |
| Last Updated: | February 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 May 16, 2013