Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

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.