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

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933998
• Other study ID #: CMI-01
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: January 28, 2014
• Start date: June 2006

Study information

• Verified date: January 2014
• Source: Carolina Musculoskeletal Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)
One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.

Locations

Country	Name	City	State
United States	Carolina Musculoskeletal Institute	Aiken	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Carolina Musculoskeletal Institute	Baylor University, Pamlab, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No