Reactive Oxygen Species in the Pathogenesis of Diabetic Complications

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00703989

Run by

Albert Einstein College of Medicine

People needed

21

Starts

2005-02-01

Expected to finish

2008-02-01

Last updated by the study team

2019-11-12

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male
• Type 1 diabetes duration between zero and fifteen years
• current insulin therapy

You may not qualify if…

• Female
• proliferative retinopathy
• microalbuminuria
• symptomatic diabetic neuropathy
• cardiovascular disease
• taking medications
• smoking

Where it is running

• GCRC, Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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