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

Carolina Musculoskeletal Institute

Status: Completed

Conditions: Diabetic Peripheral Neuropathy

Treatments: Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00933998

CMI-01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Metanx

Experimental group

Description:

Metanx bid for 2 weeks then daily. Compare to non treated patient population

Treatment:

Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)