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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
The purpose of this study is to determine whether benfotiamine supplementation can reduce markers of microvascular complications in type 1 diabetic patients.
Despite intensive strategies designed to achieve good metabolic control, diabetic patients are still at a markedly increased risk of eye and kidney disease, nerve damage, limb amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. It has recently been shown that supplementation with lipid soluble vitamin B1 (benfotiamine) in diabetic rats could effectively block three major biochemical pathways of hyperglycemic damage. It has also been shown that supplementation prevented the development of experimental diabetic retinopathy and nephropathy, without changes in glycemic control. However, the applicability of the above findings to humans is unknown, and the diabetic late complications in experimental animals do not in every aspect mirror the human diabetic complications.
This project will allow us to evaluate the potential of benfotiamine to reduce or prevent the further development of microvascular disease in type 1 diabetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benfotiamine | Experimental | Benfotiamine 300mg/day |
|
| Placebo | Placebo Comparator | Placebo for benfotiamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo for benfotiamine |
| |
| Benfotiamine |
| Measure | Description | Time Frame |
|---|---|---|
| Lower-limb nerve conduction velocity | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum advanced glycation end products (AGEs) and markers of inflammation (CRP, IL-6, VCAM-1) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristian F Hanssen, MD, PhD | University Hospital, Aker | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aker University Hospital | Oslo | 0514 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22446172 | Derived | Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. doi: 10.2337/dc11-1895. Epub 2012 Mar 23. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C013835 | benphothiamine |
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| Drug |
300mg/day |
|
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |