Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

NCT01503892 — Not applicable, Unknown, 100 participants, St. Luke's Hospital and Health Network, Pennsylvania

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Registry	NCT01503892, acronym SLHN2011-18
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	100 (Estimated)
Sponsor	St. Luke's Hospital and Health Network, Pennsylvania (Other); collaborators: Goldfarb Foundation, Pamlab, L.L.C.
Conditions	Diabetes, Peripheral Neuropathy
Interventions	Metanx, Placebo (Dietary supplement, drug)
Dates	start 2011-12-01, primary completion 2013-10-01 (estimated), first posted 2012-01-04, last updated 2012-07-17
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Drug: Placebo	The control group will receive placebo pill twice daily for twelve months.
Metanx	Active comparator	Dietary Supplement: Metanx	Metanx group will receive one pill twice daily for twelve months.

Metanx (Dietary supplement): Metanx- one tablet twice daily for twelve months
Placebo (Drug): Placebo- one tablet twice daily for twelve months.

+Outcome measures

Primary outcomes

Increased intraepidermal nerve fiber density [1 year]: 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

Secondary outcomes

Subjective improvement [1 year]: Improvement in the subjective score versus the placebo group.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Type 2 Diabetics
* Pre-diabetics
* Symptoms of peripheral neuropathy

Exclusion Criteria:

* Pregnancy
* Under age 18
* HIV (+)

+Locations (1)

Facility	City	Country	Status
St. Luke's Hospital and Health Network	Bethlehem, Pennsylvania	United States	Recruiting

+Investigators

Edwin S. Hart III, DPM, Principal investigator, St. Luke's Hospital and Health Network