Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

Study Overview
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Brief Summary
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This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.

Official Title
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Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

Conditions
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Diabetes, Peripheral Neuropathy

Intervention / Treatment
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* Dietary Supplement: Metanx
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetics Pre-diabetics Symptoms of peripheral neuropathy Exclusion Criteria: Pregnancy Under age 18 HIV (+)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The control group will receive placebo pill twice daily for twelve months. | Drug: Placebo<br>* Placebo- one tablet twice daily for twelve months.<br>|
| Active Comparator: Metanx<br>Metanx group will receive one pill twice daily for twelve months. | Dietary Supplement: Metanx<br>* Metanx- one tablet twice daily for twelve months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased intraepidermal nerve fiber density | If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective improvement | Improvement in the subjective score versus the placebo group. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small Fiber Neuropathy, Metanx Effect on Small Fiber Neuropathy, Metanx Effect on Diabetic Peripheral Neuropathy