An interventional study of 12 lead Holter and CGM Continuous Glucose Monitoring in Diabetes Mellitus Type 2 and End Stage Renal Disease, sponsored by RWTH Aachen University. Completed at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-20.
Sponsored by RWTH Aachen University · Not applicable, Interventional, and Prevention
Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest that beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population. However, no results from large-scale clinical outcome trials with beta-blockers exist in this patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be justified due to potential harmful side-effects such as AV-block or hypotension. In addition, we are lacking identified ECG surrogate parameters for SCD in this high-risk population and on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions.
Therefore, the present study will identify surrogate parameters of SCD in hemodialysis patients with T2DM and in an interventional trial investigate the suppressive effect of beta-blockers on these identified ECG markers.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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12 lead holter for 7 days CGM = continuous Glucose Monitoring
Device: 12 lead Holter · Device: CGM Continuous Glucose Monitoring
12 lead Holter measurements will be performed for 7 days
CGM will be performed continously for 7 days
ECG surrogate markers compared to cardiac events
Recruiting Period: October 2013 - April 2014 (6 months)/ Last patient out: April 2014/ Data cleaning, processing, analysis, study report: May 2014 - October 2014 (6 months)
Time frame: Analysis will be performed after last patient is out
Continuous glucose monitoring is performed to identify episodes of hypoglycaemia
Recruiting/active Period: October 2013 - April 2014 (6 months)/ Last patient out: April 2014/ Data cleaning, processing, analysis, study report: May 2014 - October 2014 (6 months)
Time frame: Analysis will be done after last patient is out
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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RWTH Aachen University