Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial

Conditions
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Type 2 Diabetes, Vitamin D Insufficiency

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Type 2 diabetes Patients of Danish extraction Vitamin D insufficiency (1,25OHvitD < 50 nmol/l) Exclusion Criteria: Nephropathy (Urea > 12 mmol/l) S-calcium > 2,52 mmol/L Primary hyperparathyroidism Serious disease Malabsorption Sarcoidosis Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecalciferol<br> | Drug: Cholecalciferol<br>* 8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks<br>|
| Placebo Comparator: Placebo pill<br> | Drug: Cholecalciferol<br>* 8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion and insulin resistance |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control, lipid status, inflammatory markers, BMD |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Vitamin D insufficiency, Insulin secretion, Insulin sensitivity, Pulsatility