Type 1 Diabetes Clinical Trial
Official title:
The Role of the Glucosamine Pathway and Reactive Oxygen Species in the Pathogenesis of Diabetic Complications
Verified date | June 2008 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy and incipient nephropathy in these models. In cultured vascular cells, it also reduces aldose reductase gene expression, activity, and sorbitol levels. It does so by activating the enzyme transketolase. α-lipoic acid, a potent antioxidant, has also been reported to reduce both diabetic microvascular and macrovascular complications in animal models. To determine whether benfotiamine in combination with α-lipoic acid would normalize markers of ROS-induced pathways of complications in humans, we performed a pilot study in subjects with Type 1 diabetes using one daily dose of benfotiamine in combination with α-lipoic acid.
Status | Completed |
Enrollment | 21 |
Est. completion date | February 2008 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Male - Type 1 diabetes duration between zero and fifteen years - current insulin therapy Exclusion Criteria: - Female - proliferative retinopathy - microalbuminuria - symptomatic diabetic neuropathy - cardiovascular disease - taking medications - smoking |
Country | Name | City | State |
---|---|---|---|
United States | GCRC, Albert Einstein College of Medicine | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine | Juvenile Diabetes Research Foundation, National Institutes of Health (NIH) |
United States,
Brownlee M. The pathobiology of diabetic complications: a unifying mechanism. Diabetes. 2005 Jun;54(6):1615-25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intracellular advanced glycation endproducts | four weeks | ||
Primary | hexosamine pathway | four weeks | ||
Primary | prostacyclin synthase activity | four weeks |
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