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| ID | Type | Description | Link |
|---|---|---|---|
| NFR 184766/V50 |
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| Name | Class |
|---|---|
| University Hospital of North Norway | OTHER |
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The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cholecalciferol 20.000 IU per week for 5 years |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Drug | 20.000 IU cholecalciferol per week for 5 years versus placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| development of diabetes type 2 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| change in glucose metabolism | 5 years | |
| change in lipid status | 5 years | |
| change in mood |
| Measure | Description | Time Frame |
|---|---|---|
| Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system | The response to oral glucose tolerance test (fasting and 2 h blood glucose, serum insulin, C-peptide, measures of insulin resistiance as well as metabolic parameters (lipids, blood pressure)) will be evaluated in the results at the 1-year visit in relation to genetic polymorphisms in the vitamin D system |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Jorde, Professor | University of Tromso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tromso | Tromsø | 9037 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26829443 | Derived | Jorde R, Sollid ST, Svartberg J, Schirmer H, Joakimsen RM, Njolstad I, Fuskevag OM, Figenschau Y, Hutchinson MY. Vitamin D 20,000 IU per Week for Five Years Does Not Prevent Progression From Prediabetes to Diabetes. J Clin Endocrinol Metab. 2016 Apr;101(4):1647-55. doi: 10.1210/jc.2015-4013. Epub 2016 Feb 1. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Placebo capsule once a week, identical to cholecalciferol capsule |
|
| 5 years |
| change in BMD hip | 5 years |
| change in intima media thickness carotid artery | 5 years |
| change in frequency of infections | 5 years |
| change in blood pressure | 5 years |
| Change in Insulin sensitivity | 5 years |
| change in HbA1c | 5 years |
| change in weight | 5 years |
| change in telomer length | 5 years |
| 1 year |
| D004700 | Endocrine System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |