Diabetes Mellitus Clinical Trial
Official title:
A Randomized Double Blinded Pilot Study of Oral Thiamine in the Symptomatic Treatment of Painful Diabetic Peripheral Neuropathy
This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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