Type-2 Diabetes MellitusNCT01422057
Risk Prediction in Type II Diabetics With Ischemic Heart Disease
An observational study of Type-2 Diabetes Mellitus and Ischemic Heart Disease, run by Thebiosignals.com at 1 site in Germany.
Trial summary
The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type-2 Diabetes Mellitus, Ischemic Heart Disease
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 2016
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.
Who may be able to join
- type-2 diabetes
- coronary artery disease
Who cannot join
- age >80 years
- acute coronary syndrome
- life expectancy <1 year
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology
Tübingen, Tübingen, 72076
Christine Zürn, MD, +49 7071 29 83153, christine.zuern@med.uni-tuebingen.de
Axel Bauer, MD
About this study
Official title: Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function
The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease
Read the detailed description
In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected.
In the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity.
The correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).
- Conditions
- Type-2 Diabetes Mellitus, Ischemic Heart Disease
- Keywords
- diabetes, coronary artery disease, ischemic heart disease, autonomic function, heart rate turbulence, deceleration capacity, severe autonomic failure
- Medical subject headings
- Myocardial Ischemia, Diabetes Mellitus, Coronary Artery Disease, Pure Autonomic Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular event
Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke
Measured: 2 years
Secondary outcomes (3)
Cardiovascular mortality
Measured: 2 years
sudden cardiac death
Measured: 2 years
Total mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-2 Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thebiosignals.com
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Bauer, Thebiosignals.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422057
- Sponsor's protocol ID
- 402/2009BO2-2
- Status last verified
- Feb 2014
- First submitted
- 9 Aug 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function
- ClinicalTrials.gov ID
- NCT01422057
- Acronym / sponsor ID
- 402/2009BO2-2
- Conditions
- Type-2 Diabetes Mellitus, Ischemic Heart Disease
- Keywords
- diabetes, coronary artery disease, ischemic heart disease, autonomic function, heart rate turbulence, deceleration capacity, severe autonomic failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Thebiosignals.comUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2016 (estimated)
- First posted
- 23 Aug 2011 (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.
The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease
Detailed description
In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected.
In the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity.
The correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.
Key inclusion criteria (2 listed)
- type-2 diabetes
- coronary artery disease
Key exclusion criteria (4 listed)
- age >80 years
- acute coronary syndrome
- life expectancy <1 year
- unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major cardiovascular event
Time frame: 2 years
Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke
3 secondary outcomes
Cardiovascular mortality
Time frame: 2 years
sudden cardiac death
Time frame: 2 years
Total mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type-2 Diabetes Mellitus and Ischemic Heart Disease, run by Thebiosignals.com at 1 site 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Zürn, MD (+49 7071 29 83153, christine.zuern@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular event (time frame: 2 years). 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 6 Feb 2014.