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

NCT00933998 | Completed

• 1 other identifier: CMI-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

DPN

Outcome Measures

Primary Outcomes (1)

• Epidermal Nerve Density Count

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

  2 years

Study Arms (1)

Metanx

EXPERIMENTAL

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

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

Interventions

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

One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.

Also known as: Metanx

Metanx

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of back problems (Surgery or ECSI) or other large fiber neuropathies
• History of chemotherapy
• History of chemical exposure

Sponsors & Collaborators

• Carolina Musculoskeletal Institute: lead
• Pamlab, L.L.C.: collaborator
• Baylor University: collaborator

Study Sites (1)

Carolina Musculoskeletal Institute

Aiken, South Carolina, 29841, United States

Location

MeSH Terms

Interventions

metanx; 5-methyltetrahydrofolate; mecobalamin; Pyridoxal Phosphate

Intervention Hierarchy (Ancestors)

Pyridoxal; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Podiatry Division

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: June 1, 2006
• Primary Completion: October 1, 2008
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

US (1)