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| Name | Class |
|---|---|
| Pamlab, L.L.C. | INDUSTRY |
| Baylor University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metanx | Experimental | Metanx bid for 2 weeks then daily. Compare to non treated patient population |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Musculoskeletal Institute | Aiken | South Carolina | 29841 | United States |
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| ID | Term |
|---|---|
| C575384 | metanx |
| C005984 | 5-methyltetrahydrofolate |
| C019476 | mecobalamin |
| D011732 | Pyridoxal Phosphate |
| ID | Term |
|---|---|
| D011730 | Pyridoxal |
| D025101 | Vitamin B 6 |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 |
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|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |