Study protocol: a randomised placebo-controlled clinical trial to study the effect of vitamin D supplementation on glycaemic control in type 2 Diabetes Mellitus SUNNY trial

BMC Endocrine Disorders

Suat Simsek¹  Paul Lips¹  Edwin ten Boekel⁴  Frank Stam³  Hans van Wijland²  Yvonne HM Krul-Poel³ 

[1] Department of Internal Medicine/Endocrinology, VU University Medical Centre, Amsterdam, The Netherlands;Department of Family Medicine, Alkmaar, The Netherlands;From the Department of Internal Medicine, Medical Centre Alkmaar, PO Box 7057, 1815 JD, Wilhelminalaan 12, Alkmaar, The Netherlands;Department of Clinical Chemistry, Haematology & Immunology, Medical Centre Alkmaar, Alkmaar, The Netherlands

关键词: Insulin resistance;    Advanced glycation end products;    Quality of life;    Type 2 diabetes mellitus;    Vitamin D;   

Others  :  863107
DOI  :  10.1186/1472-6823-14-59

 received in 2013-07-23, accepted in 2014-07-14,  发布年份 2014

【 摘 要 】

Background

Besides the classical role of vitamin D on calcium and bone homeostasis, vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus. However, it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus. There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control.

The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus.

Methods/design

In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D₃ at monthly intervals. The primary outcome measure is the change in glycated haemoglobin level between baseline and six months. Secondary outcome measures include blood pressure, anthropometric parameters, lipid profile, insulin resistance, quality of life, advanced glycation end products and safety profiles. Quality of life will be measured by The Short Form (SF-36) Health Survey questionnaire. Advanced glycation end products are measured by an AGE-reader.

Discussion

This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus. Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus.

Trial registration

The Netherlands trial register: NTR3154

【 授权许可】

   
2014 Krul-Poel et al.; licensee BioMed Central Ltd.

【 图 表 】

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