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| ID | Type | Description | Link |
|---|---|---|---|
| 06H-2958-9918 |
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The purpose of this pilot study is to determine whether vitamin C supplementation is beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type 2 diabetes.
Painful diabetic peripheral neuropathy (DPN), a condition characterized by pain affecting the feet, legs and hands that is often characterized as burning or a "pins and needles" sensation, is estimated to affect up to 66% of the U.S. diabetic population. This pilot study will examine the effect of a daily dose of ascorbic acid, a known aldose reductase inhibitor, versus placebo, and the effect that it can have on intracellular erythrocyte (red blood cell) sorbitol levels, aldose reductase activity and aldose reductase enzyme levels utilizing benchtop methods, and effects on clinical DPN-associated pain reporting and changes in quantitative sensory testing in the lower extremities via touch discrimination and vibratory sensory testing in patients with Type 2 Diabetes Mellitus (T2DM) over the course of 90 days of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | 1000mg Placebo capsules orally twice daily for 90 days |
|
| 1 | Experimental | 1000mg Vitamin C capsules orally twice daily for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Dietary Supplement | 1000mg Vitamin C capsules orally twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intracellular erythrocyte sorbitol levels | Changes at 90 days compared to baseline | |
| Changes in aldose reductase enzyme activity | Activity at 90 days compared to baseline | |
| Changes in aldose reductase enzyme levels | Levels at 90 days compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Neuropathic Pain Scale (NPS) measurement and quantitative sensory testing in the lower extremities via touch discrimination with Semmes-Weinstein monofilaments and vibratory sensation testing | Changes at 90 days compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua J Neumiller, PharmD | Washington State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington State University, College of Pharmacy, Department of Pharmacotherapy | Spokane | Washington | 99210-1495 | United States |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo |
| Dietary Supplement |
1000mg Placebo capsules orally twice daily for 90 days |
|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |