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The main aim of the investigation is to clarify, whether vitamin D supplementation in coronary artery disease patients with vitamin D deficiency and postchallenge hyperglycemia has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell function.
An improvement of endothelial dysfunction as a cardiovascular surrogate parameter could be translated in a reduced risk for future cardiovascular events, which is of major interest, since patients with postchallenge hyperglycemia face a significantly higher cardiovascular risk than patients with normal glucose tolerance. Furthermore an improvement in insulin sensitivity and/or beta-cell function would identify vitamin D as an important strategy for the prevention of type 2 diabetes. In consideration of the rapidly increasing prevalence of diabetes and the failure of current prevention strategies this could be an important, safe and cheap way to support ongoing lifestyle modifying programs. Our study of course investigates surrogate cardiovascular and insulin sensitivity parameters. Assuming a beneficial effect of vitamin D in our study, this concept would have to be proven in further large outcome as well as diabetes prevention trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D (OleovitĀ®) | Active Comparator | vitamin D drops |
|
| Placebo | Placebo Comparator | placebo drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Drug | orally administered 2800 IU of vitamin D or placebo daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| endothelial dysfunction | Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| insulin resistance and beta-cell function | Changes in indices for insulin resistance and beta-cell function | 1 year |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R. Pieber, MD | Medical University of Graz, Graz, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Internal Medicine, Medical University of Graz | Graz | 8036 | Austria |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006943 | Hyperglycemia |
| D014808 | Vitamin D Deficiency |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006946 | Hyperinsulinism |