Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

Not Applicable

• Conditions: Diabetes; Peripheral Neuropathy
• Interventions: Drug: Placebo; Dietary Supplement: Metanx

• Registration Number: NCT01503892
• Lead Sponsor: St. Luke's Hospital and Health Network, Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-31
• Study First Posted: 2012-01-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17
• Primary Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Under age 18
• HIV (+)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The control group will receive placebo pill twice daily for twelve months.
Metanx	Metanx	Metanx group will receive one pill twice daily for twelve months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Subjective improvement	1 year	Improvement in the subjective score versus the placebo group.

Trial Locations

Locations (1)

St. Luke's Hospital and Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States