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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.
Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D < 100 nmol/L. If serum 25(OH)D > 100 placebo will be given. The cholecalciferol will be given in orange juice. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity measured with euglycemic, hyperinsulinemic clamp | Before and after the 6 months intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin secretion measured with IVGTT | At 0 and 6 months | |
| Physical activity/muscle strength | At 0 and 6 months | |
| HbA1c and fasting glucose |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gulseth Wium, MD | Contact | 4722894745 | diabeteslab@aus.no |
| Name | Affiliation | Role |
|---|---|---|
| Kåre I Birkeland, MD PhD | Oslo University Hospital - Aker | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Laboratory, Oslo University Hospital Aker | Recruiting | Oslo | 0514 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28468770 | Derived | Gulseth HL, Wium C, Angel K, Eriksen EF, Birkeland KI. Effects of Vitamin D Supplementation on Insulin Sensitivity and Insulin Secretion in Subjects With Type 2 Diabetes and Vitamin D Deficiency: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):872-878. doi: 10.2337/dc16-2302. Epub 2017 May 3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D014808 | Vitamin D Deficiency |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| 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 |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Orange juice | Other | Orange juice at randomization day and at week 5. |
|
| At 0, 3 and 6 months |
| Arterial stiffness | At 0 and 6 months |
| Differences in inflammatory markers, endothelial function and bone specific laboratory markers. | At 0, 3 and 6 months |
| Safety of this regimen of vitamin D3 supplementation; subjects will be assessed for hypercalcemia and renal dysfunction. | Entire intervention period, samples taken at 0,1,3, and 6 months |
| Change from baseline in quality of life score between groups (SF-36). | At 0 and 6 months |
| Effect on serum lipid levels and other biochemical markers | At 0, 3 and 6 months |
| Metabolomics analyses. | At 0 and 6 months |
| D004700 | Endocrine System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |