Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar

Insulin Resistance Clinical Trial

Official title: Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar

Status Recruiting

Clinical Trial Summary

There is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will decrease insulin resistance and the associated metabolic indices linked to the later development of T2DM.

Clinical Trial Description

Epidemiologically, there is an association between elevated T2DM risk and low serum levels of vitamin D and suggest that it may protect against the diseases through the improvement of insulin sensitivity as well as secretion and reducing chronic inflammation. Although some of these effects were shown in clinical studies, no study permitted the inference that vitamin D can reduce blood glucose and attenuate inflammation. Post-prandial glucose is the most sensitive to alterations in insulin sensitivity. Therefore, it is rational to examine whether vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM and to elucidate the mechanism by which this occurs, i.e. via improved insulin sensitivity or improved insulin secretion, or both. Furthermore, identifying a distinct proteomics-based signature that can be used to distinguish responders to supplementation from non-responders is critical to define the bases for inter-individual variation in response and the effect of vitamin D on the prevention of T2DM. Identification of this proteomics-based signature will enable us to tailor alternative preventive measures to adjust the vitamin D dose to non-responders, leading to more effective and precise intervention protocols. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

• NCT number: NCT02098980
• Study type: Interventional
• Source: Supreme Council Of Health, Qatar
• Contact: Mohamed Al-Thani, Ph.D.
• Phone: 97444070100
• Email: malthani@sch.gov.qa
• Status: Recruiting
• Phase: N/A
• Start date: May 2014
• Completion date: December 2017