Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

Carolina Musculoskeletal Institute20 enrolled

Overview

The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done before the patient receives Metanx. Additional quantitative sensory testing will be done at 6 and 12 months to evaluate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Peripheral Neuropathy

Interventions

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Consecutive diabetic patients entering the office (private practice) * Subjective symptoms of numbness, burning, paresthesia, etc. * Failed Monofilament of at least two points on each foot * Abnormal PSSD study * Willing to participate in protocols or study * Taking one Metanx tablet bid for 2 weeks then one Metanx tablet daily * Keep scheduled appointments for follow up studies * Report any other medical interventions, studies, or medication changes * Report any problems of medical or psycho-social matters to investigators * HgbA1c NOT monitored or specific value required for participation Exclusion Criteria: * History of back problems (Surgery or ECSI) or other large fiber neuropathies * History of chemotherapy * History of chemical exposure

Outcomes

Primary Outcomes

Epidermal Nerve Density Count

Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy

Time frame: 2 years