Diabetes Mellitus Type 2NCT02001480
Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease
A study testing 12 lead Holter and CGM Continuous Glucose Monitoring in people with Diabetes Mellitus Type 2 and End Stage Renal Disease, run by RWTH Aachen University at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, End Stage Renal Disease
- What is being tested?
- 12 lead Holter and CGM Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with diabetes mellitus type 2
- chronic hemodialysis at least since 3 months
- aged above 18 years
- written informed consent
- legally competent
Who cannot join
- intake of bets-blockker within the last four weeks
- pregnancy and breast feeding
- abuse of drugs and alcohol
- missing compliance
- life expectancy < 6 month
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Department of Internal Medicine I University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
regioMed-Kliniken GmbH
Coburg, Bavaria, 96450
University Hospital Würzburg
Würzburg, Bavaria, 97080
About this study
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.
- Conditions
- Diabetes Mellitus Type 2, End Stage Renal Disease
- Being tested
- 12 lead Holter, CGM Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 lead HolterDevice
12 lead Holter measurements will be performed for 7 days
CGM Continuous Glucose MonitoringDevice
CGM will be performed continously for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography | Other | 12 lead holter for 7 days
CGM = continuous Glucose Monitoring Receives: Device: 12 lead Holter; Device: CGM Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Analysis will be performed after last patient is out
Secondary outcomes (1)
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)
Measured: Analysis will be done after last patient is out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaus Marx, Univ.-Prof., Principal investigator, Department of Internal Medicine University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001480
- Sponsor's protocol ID
- 12-039
- Status last verified
- Jan 2016
- First submitted
- 23 Oct 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT02001480
- Acronym / sponsor ID
- 12-039
- Conditions
- Diabetes Mellitus Type 2, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiography | Other | Device: 12 lead Holter, Device: CGM Continuous Glucose Monitoring12 lead holter for 7 days CGM = continuous Glucose Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with diabetes mellitus type 2
- chronic hemodialysis at least since 3 months
- aged above 18 years
- written informed consent
- legally competent
Key exclusion criteria (5 listed)
- intake of bets-blockker within the last four weeks
- pregnancy and breast feeding
- abuse of drugs and alcohol
- missing compliance
- life expectancy < 6 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 lead Holter12 lead Holter measurements will be performed for 7 days | Device | Echocardiography |
| CGM Continuous Glucose MonitoringCGM will be performed continously for 7 days | Device | Echocardiography |
Primary outcome
ECG surrogate markers compared to cardiac events
Time frame: Analysis will be performed after last patient is out
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)
1 secondary outcome
Continuous glucose monitoring is performed to identify episodes of hypoglycaemia
Time frame: Analysis will be done after last patient is out
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaus Marx, Univ.-Prof. principal investigator
Department of Internal Medicine University Hospital Aachen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 lead Holter and CGM Continuous Glucose Monitoring in people with Diabetes Mellitus Type 2 and End Stage Renal Disease, run by RWTH Aachen University at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG surrogate markers compared to cardiac events (time frame: Analysis will be performed after last patient is out). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.