Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)

St. Luke's Hospital and Health Network

Status: Unknown

Conditions: Peripheral Neuropathy; Diabetes

Treatments: Drug: Placebo; Dietary Supplement: Metanx

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01503892

StLukeHHN

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy
• Under age 18
• HIV (+)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The control group will receive placebo pill twice daily for twelve months.

Treatment:

Drug: Placebo

Metanx

Active Comparator group

Description:

Metanx group will receive one pill twice daily for twelve months.

Treatment:

Dietary Supplement: Metanx