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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Regionshospitalet Silkeborg | OTHER |
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The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.
There is increasing evidence that vitamin D affects the risk of diabetes. The role of vitamin D in type 2 diabetes is suggested by cross sectional studies, where an inverse association between vitamin D status and the development of type 2 diabetes has been found. Moreover supplementation with calcium and vitamin D may attenuate increases in glycemia and insulin resistance in healthy older adults with IFG. However further research is needed to confirm these findings and to determine possible mechanisms of the preventive effect from vitamin D against diabetes. The aim of this study is to examine the effect on metabolic parameters such as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin secretion in patients with type 2 diabetes and vitamin D insufficiency before and after a 12-week period of treatment with high doses of vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Active Comparator |
| |
| Placebo pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | 8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin secretion and insulin resistance | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control, lipid status, inflammatory markers, BMD | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lotte Oeskov, MD | Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Unit, Medical Department M, Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25044176 | Derived | Kampmann U, Mosekilde L, Juhl C, Moller N, Christensen B, Rejnmark L, Wamberg L, Orskov L. Effects of 12 weeks high dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency - a double-blind, randomized, placebo-controlled trial. Metabolism. 2014 Sep;63(9):1115-24. doi: 10.1016/j.metabol.2014.06.008. Epub 2014 Jun 19. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |