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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metanx

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Metanx

Eligibility Criteria

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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