Diabetes Clinical Trial
The aim of this research is to study how vitamin D affects various aspects of the disease
process, such as inflammation, coagulation (ADAMTS13 and WVF) and miRNAs, in Diabetic kidney
disease hemodialysis patients.
Diabetes mellitus (DM) is one of the most common chronic diseases in nearly all countries.
Diabetic kidney disease (DKD) traditionally has been referred to as diabetic nephropathy and
is one of the microvascular complications of diabetes. Diabetic kidney disease (DKD) occurs
in 25%-40% of patients with diabetes .
Some studies have shown that the high risk of cardiovascular disease in diabetic patients
with nephropathy is associated with increased plasma levels of von Willebrand factor (VWF)
and decreased ADAMTS13 levels. VWF is a glycoprotein that plays an important role in
platelet thrombus formation, whereas ADAMTS13 is a proteolytic enzyme that is responsible
for degradation of large multimers of VWF released in the plasma by endothelial cells and
platelets. Patients with both chronic kidney disease and diabetes have been shown to have
higher plasma levels of VWF and decreased ADAMTS13 activity compared to healthy controls.
Increased plasma levels of VWF, which reflects damage to endothelial cells and a
hypercoagulability state, have been reported in atherosclerosis and diabetes. Thus, VWF and
ADAMTS13 seem to be important players in the interface between diabetic nephropathy,
hypercoagulability and atherosclerotic cardiovascular disease. Vitamin D deficiency is a
risk factor for DM and hypertension. The investigators previous studies showed that adding
calcitriol (activated vitamin D) to endothelial and vascular smooth muscle cells
significantly down-regulated the inflammatory response of gene and protein expression
involved in the nuclear factor kappa-light-chain-enhancer of activated B cells (NFĸB) signal
transduction pathway. Micro RNA (miRNA) are short noncoding RNAs, 22-25 nucleotides long. As
an endogenous production transcript, miRNAs can bind to the 3 untranslated regions (3 UTR)
of its target messenger RNA (mRNA) in an imperfect, complementary manner, leading to
post-transcriptional gene silencing. As a result, miRNAs can inhibit gene expression via
mRNA degradation, translation inhibition, or transcriptional inhibition.The critical role of
miRNAs has been established in several cellular and biologic processes, such as
proliferation, differentiation, and development, and in the regulation of genes related to
immune responses, cancer, and insulin secretion. MiRNA are involved in various biological
processes and become novel biomarkers, modulators and therapeutic targets for diseases such
as cancer, atherosclerosis, and DM.
Significance: The high prevalence of cardiovascular morbidity and mortality in patients with
DM on chronic hemodialysis remains a significant clinical problem and the finding of
potential new biomarkers should be further investigated. This study aims to establish a link
between ADAMTS13, VWF miRNA expression and vitamin D levels that can contribute to the
development of new treatments for hemodialysis patients with diabetes.
Methods: Each hemodialysis patient with diabetes in the investigators institute will be
asked to participate in the study. After explaining the research goals, patients that agree
to participate will sign an informed consent. The investigators estimate that the study will
include 70 patients. Each patient will be assessed by a physician and 4 vials of blood will
be taken while the patient is connected to the dialysis machine. The blood will be sent to
the laboratory to check: 1) chemistry; 2) 1-25 vitamin D and 25- vitamin D levels; 3)
ADAMTS13 activity and VWF; and 4) miRNA extraction. The patients will be grouped according
to vitamin D levels (deficient /sufficient), and ADAMTS13, VWF and miRNA expression will be
compared between the groups.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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