Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics|
- Increased intraepidermal nerve fiber density [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
- Subjective improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]Improvement in the subjective score versus the placebo group.
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
The control group will receive placebo pill twice daily for twelve months.
Placebo- one tablet twice daily for twelve months.
Active Comparator: Metanx
Metanx group will receive one pill twice daily for twelve months.
Dietary Supplement: Metanx
Metanx- one tablet twice daily for twelve months
|Contact: Edwin S. Hart III, DPMfirstname.lastname@example.org|
|United States, Pennsylvania|
|St. Luke's Hospital and Health Network||Recruiting|
|Bethlehem, Pennsylvania, United States, 18015|
|Contact: Edwin S. Hart III, DPM 610-868-4300 email@example.com|
|Principal Investigator:||Edwin S. Hart III, DPM||St. Luke's Hospital and Health Network|