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

Not Applicable

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)

• Registration Number: NCT00933998
• Lead Sponsor: Carolina Musculoskeletal Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-10
• Study First Submitted: 2009-07-07
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metanx	Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)	Metanx bid for 2 weeks then daily. Compare to non treated patient population

Primary Outcome Measures

Name	Time	Method
Epidermal Nerve Density Count	2 years	Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy

Trial Locations

Locations (1)

Carolina Musculoskeletal Institute; 🇺🇸 Aiken, South Carolina, United States