ClinicalTrials.gg
Status unknownNCT02245633Updated Sep 19, 2014

Correlation Between Vitamin D Levels to ADAMTS13 , VWF and Micro RNA Expression in Diabetic Hemodialysis Patients

An observational study in Hemodialysis Patients and Diabetes, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by Meir Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Hemodialysis Patients
  • Diabetes

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03

In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 70 is below the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.

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Lead sponsor

Meir Medical Center is the lead sponsor of 400 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemodialysis patients with diabetes at Meir Medical Center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of chronic kidney disease - hemodialysis patient with diabetes

Exclusion criteria

Exclusion Criteria:

  • Hemodialysis patient - non diabetic
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
70 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • vitamin D levels deficient

    Diabetic hemodialysis patients with vitamin D levels deficient

  • vitamin D levels sufficient

    Diabetic hemodialysis patients with vitamin D levels sufficient

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What researchers measure

Primary outcomes

  1. ADAMTS13 levels in diabetic hemodialysis patients

    blood will be collected from diabetic hemodialysis patients that will arrived to the hospital for receive dialysis for analysis ADAMTS13 levels

    Time frame: 1 day

Secondary outcomes

  1. VWF levels in diabetic hemodialysis patients

    blood will be collected from diabetic hemodialysis patients that will arrived to the hospital for receive dialysis for analysis VWF levels

    Time frame: 1 day

Other outcomes

  1. miRNA expression in plasma from diabetic hemodialysis patients

    blood will be collected from diabetic hemodialysis patients that will arrived to the hospital for receive dialysis for extract miRNA

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Nephrology dept. Meir Medical Center
    Kfar Saba, 44281, Israel
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02245633
Responsible party
Sydney Ben Shitrit (Dr., Meir Medical Center) — Principal investigator
First posted
Sep 19, 2014
Start date
Sep 2014
Primary completion
Feb 2015 (estimated)
Completion
Sep 2015 (estimated)
Last update
Sep 19, 2014

Study contacts

Sydney bensitrit, MD
Contact
sydneybe@clalit.org.il
+972-9-7472517
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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