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Sponsored by: |
Loma Linda University |
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Information provided by: | Loma Linda University |
ClinicalTrials.gov Identifier: | NCT00279266 |
This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.
Condition | Intervention |
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Peripheral Neuropathy Diabetes Mellitus Diabetes Complications |
Drug: Thiamine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Double Blinded Pilot Study of Oral Thiamine in the Symptomatic Treatment of Painful Diabetic Peripheral Neuropathy |
Estimated Enrollment: | 28 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | June 2006 |
It is estimated that more then 5 million people in the United States suffer from Diabetes Mellitus, and of these up to 80% suffer from painful diabetic peripheral neuropathy. Multiple medications have been tried for the treatment of painful diabetic neuropathy. These medications are directed at symptomatic relief and do not address the underlying cause of painful peripheral neuropathy. Thiamine is a water-soluble vitamin that participates in carbohydrate metabolism. Deficiency of thiamine causes beriberi, characterized by painful peripheral neuropathy and cardiomyopathy. Basic research has suggested that thiamine deficiency may also be involved in the etiology of diabetic neuropathy by preventing the glycation of nerve fibers as well as apoptosis of endothelial cells. A study in the developing world found that oral thiamine and pyridoxine were helpful in improving the pain experienced in diabetic peripheral neuropathy as well as improving signs of neuropathy seen on neurological examination. A screening study of patients with type II diabetes found that 76% of patients tested had a low serum thiamine level. Our study will examine the effect of oral thiamine supplementation on the symptom of pain in painful diabetic peripheral neuropathy. In addition we will follow serum thiamine levels to see if clinical change correlates with changes in serum thiamine levels
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of Diabetes Mellitus Painful diabetic neuropathy for > six months with a score of >40mm on a visual pain analog scale Age >18 years Hemoglobin A1c obtained within the last 3 months. Willingness and ability to comply with the study requirements and give informed consent.
Exclusion Criteria:
Known history of alcohol abuse, recreational drug abuse, thyroid dysfunction, syphilis, multiple myeloma, known nutrient deficiency, history of gastric bypass surgery or HIV. Hgb A1c>11
United States, California | |
Loma Linda University Department of Neurology | |
Loma Linda, California, United States, 92354 |
Principal Investigator: | Rodolfo Escutin, MD | Loma Linda University |
Study ID Numbers: | OSR#55288 |
Study First Received: | January 18, 2006 |
Last Updated: | October 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00279266 History of Changes |
Health Authority: | United States: Institutional Review Board |
Diabetic Peripheral Neuropathy Peripheral Neuropathy Diabetes Mellitus |
Vitamin B Complex Metabolic Diseases Diabetic Neuropathies Diabetes Mellitus Thiamine Endocrine System Diseases Trace Elements Pain Vitamin B1 |
Neuromuscular Diseases Peripheral Nervous System Diseases Vitamins Thiamin Micronutrients Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Diabetes Complications |
Metabolic Diseases Vitamin B Complex Diabetic Neuropathies Growth Substances Physiological Effects of Drugs Nervous System Diseases Diabetes Mellitus Thiamine |
Endocrine System Diseases Pharmacologic Actions Neuromuscular Diseases Peripheral Nervous System Diseases Vitamins Micronutrients Glucose Metabolism Disorders Diabetes Complications |