Ignite Creation Date:
2024-05-06 @ 1:09 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01741181
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2012-11-30
Brief Title:
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
Official Title:
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 and Low 25OHD Concentrations Does it Help to Improve Endothelial Function-The DIMENSION TRIAL
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIMENSION
Brief Summary:
Background and Objectives
The presence of vitamin D deficiency in patients with type 2 diabetes mellitus T2DM is associated with an increased risk of cardiovascular disease CVD We aim to see whether supplementation of vitamin D in these patients helps to improve the endothelial function EF a surrogate marker of CVD risk
Hypothesis Vitamin D supplementation in patients with T2DM and low serum 25OH D concentrations 30ngml will improve EF as measured by the Endo-PAT machine by 04 units 30 improvement over baseline andor will result in a increase of EPCs CD133KDR and CD45dim CD34KDR
The investigators will test this hypothesis by comparing 2 groups of T2DM patients randomized to placebo or vitamin D3 for 16 weeks
Methods
This is a 16 weeks trial in which 120 T2DM patients will be screened with the aim to recruit 60 T2DM patients with vitamin D deficiency or insufficiency Out of these 60 patients 30 patients will be started on vitamin D supplementation and 30 patients will be given a matched placebo Endothelial function EF will be checked before and after supplementation to see a change in EF
Significance of Project
If this study shows a significant improvement of EF it would justify larger scale studies to show that vitamin D supplementation in patients with T2DM mitigates CVD risk and vitamin D supplementation in patients with T2DM and vitamin D deficiency to improve CVD risk
The presence of vitamin D deficiency in patients with type 2 diabetes mellitus T2DM is associated with an increased risk of cardiovascular disease CVD We aim to see whether supplementation of vitamin D in these patients helps to improve the endothelial function EF a surrogate marker of CVD risk
Hypothesis Vitamin D supplementation in patients with T2DM and low serum 25OH D concentrations 30ngml will improve EF as measured by the Endo-PAT machine by 04 units 30 improvement over baseline andor will result in a increase of EPCs CD133KDR and CD45dim CD34KDR
The investigators will test this hypothesis by comparing 2 groups of T2DM patients randomized to placebo or vitamin D3 for 16 weeks
Methods
This is a 16 weeks trial in which 120 T2DM patients will be screened with the aim to recruit 60 T2DM patients with vitamin D deficiency or insufficiency Out of these 60 patients 30 patients will be started on vitamin D supplementation and 30 patients will be given a matched placebo Endothelial function EF will be checked before and after supplementation to see a change in EF
Significance of Project
If this study shows a significant improvement of EF it would justify larger scale studies to show that vitamin D supplementation in patients with T2DM mitigates CVD risk and vitamin D supplementation in patients with T2DM and vitamin D deficiency to improve CVD risk
Detailed Description:
Overall Aims Type 2 Diabetes Mellitus T2DM is increasingly more prevalent in Singapore and is a high cardiovascular diseases CVD risk factor 12 The presence of low serum 25OHD concentrations 30ngml has also been classified as an independent predictor of CVD34 and has been seen to be more prevalent in T2DM 5-7 We aim to see whether replacement with vitamin D in these patients helps to mitigate CVD risk Since endothelial dysfunction is one of the earliest manifestations of CVD and is a very robust surrogate marker we aim to measure the endothelial function EF before and after vitamin D supplementation to evaluate for beneficial impact on this endpoint
Specific Aims Although there are some small scale studies done with a single high dose replacement of vitamin D2D3 no studies have been done using regular daily supplementation with vitamin D3 and with measurement of EF using the Endo-PAT machine or measurement of endothelial progenitor cells EPCsWe are doing this pilot study to see whether replacement with vitamin D results in an improvement of EF as measured using the Endo-PAT and estimation of EPCs and some biomarkers as independent established surrogate markers of CVD risk The estimation of endothelial progenitor cells has been proposed as a surrogate marker of vascular dysfunction and is known to be reduced in patients with cardiovascular risk factors 8 The no of circulating endothelial cells CECs and endothelial microparticles have been seen to be elevated in patients with cardiovascular risk factors and DM and has also been proposed as a effective surrogate marker We aim to quantify the no of endothelial progenitor cells EPCs staining positive for CD133KDR kinase insert domain-containing receptorCD34KDR and CD45dim CD34KDR CECs CD 146CD45- and EMPs derived from endothelial progenitors CD45-CD146CD34CD117 and from mature endothelial cells CD45-CD146CD34CD117-using flow cytometry
Primary Hypothesis
Vitamin D supplementation in patients with T2DM and low serum 25OH D concentrations 30ngml will improve EF as measured by the Endo-PAT machine by 04 units 30 improvement over baseline andor will result in a increase of EPCs CD133KDR and CD45dim CD34KDR The investigators will test this hypothesis by comparing 2 groups of T2DM patients randomized to placebo or vitamin D3 for 16 weeks
Secondary Objectives
To explore the prevalence of low serum 25OH D concentrations 30ngml in T2DM patients and evaluate the difference in the EF in the two groups To see whether vitamin D supplementation helps to further improve other parameters such as biomarkers blood pressure BMI urine albumin-to-creatinine ratio ACR lipid profile of T2DM patients
Specific Aims Although there are some small scale studies done with a single high dose replacement of vitamin D2D3 no studies have been done using regular daily supplementation with vitamin D3 and with measurement of EF using the Endo-PAT machine or measurement of endothelial progenitor cells EPCsWe are doing this pilot study to see whether replacement with vitamin D results in an improvement of EF as measured using the Endo-PAT and estimation of EPCs and some biomarkers as independent established surrogate markers of CVD risk The estimation of endothelial progenitor cells has been proposed as a surrogate marker of vascular dysfunction and is known to be reduced in patients with cardiovascular risk factors 8 The no of circulating endothelial cells CECs and endothelial microparticles have been seen to be elevated in patients with cardiovascular risk factors and DM and has also been proposed as a effective surrogate marker We aim to quantify the no of endothelial progenitor cells EPCs staining positive for CD133KDR kinase insert domain-containing receptorCD34KDR and CD45dim CD34KDR CECs CD 146CD45- and EMPs derived from endothelial progenitors CD45-CD146CD34CD117 and from mature endothelial cells CD45-CD146CD34CD117-using flow cytometry
Primary Hypothesis
Vitamin D supplementation in patients with T2DM and low serum 25OH D concentrations 30ngml will improve EF as measured by the Endo-PAT machine by 04 units 30 improvement over baseline andor will result in a increase of EPCs CD133KDR and CD45dim CD34KDR The investigators will test this hypothesis by comparing 2 groups of T2DM patients randomized to placebo or vitamin D3 for 16 weeks
Secondary Objectives
To explore the prevalence of low serum 25OH D concentrations 30ngml in T2DM patients and evaluate the difference in the EF in the two groups To see whether vitamin D supplementation helps to further improve other parameters such as biomarkers blood pressure BMI urine albumin-to-creatinine ratio ACR lipid profile of T2DM patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None