An interventional study of benfotiamine, α-lipoic acid in Type 1 Diabetes, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Treatment
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.
The glycemic status of study patients was assessed by measuring baseline values of HbA1c, fructosamine, and fasting plasma glucose. Mean HbA1c was 8.7+ 0.7%, mean fructosamine was 421+29 mg/dl (normal range 174-286 mg/dl), and mean fasting blood glucose was 198+44 mg/dl.
At day 0, subjects levels of markers of two benfotiamine-sensitive pathways were determined: intracellular advanced glycation endproduct (AGE) formation, as reflected by a marker of increased intracellular methylglyoxal adducts in endothelial cells, angiopoietin 2 and hexosamine pathway activity, measured by determination of N-acetylglucosamine-modified protein in circulating monocytes. PKC activity in circulating monocytes could not be measured because the amount of blood required exceeded that approved by the Committee on Clinical Investigations. Serum levels of 6-keto-PGF-1 , a stable product produced by the nonenzymatic hydration of the antiatherogenic mediator prostacyclin were also determined. Subjects then took benfotiamine 300 mg twice a day, (Advanced Orthomolecular Research, Calgary, AB,CANADA) and slow-release α-lipoic acid (600 mg twice a day) (MRI, San Francisco, CA) for 28 days. Blood was obtained at day 0, day 15, and day 28.
Data were analyzed using 1-factor analysis of variance to compare the means of all the groups. The Tukey-Kramer multiple comparisons procedure was used to determine which pairs of means were different.
218 studies on the registry are indexed under Diabetes Complications; 48 are open to participants now.
This study's enrollment of 21 is below the median of 70 across 133 interventional studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.
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Exclusion Criteria:
Patients with Type 1 diabetes
Dietary Supplement: benfotiamine, α-lipoic acid
Age-matched male subjects without Type 1 diabetes
benfotiamine 300 mg twice a day, (Advanced Orthomolecular Research, Calgary, AB,CANADA) and slow-release α-lipoic acid (600 mg twice a day) (MRI, San Francisco, CA) for a total duration of four weeks
Also known as: benfotiamine 300 mg .slow-release, α-lipoic acid (600 mg twice a day)
intracellular advanced glycation endproducts
Time frame: four weeks
hexosamine pathway
Time frame: four weeks
prostacyclin synthase activity
Time frame: four weeks
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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Albert Einstein College of Medicine