Diabetes MellitusNCT00286572
Long-term Mortality in Diabetics Undergoing Major Surgery
An observational study of Diabetes Mellitus and Coronary Heart Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Coronary Heart Disease, Major Non-cardiac Surgery
- How many people
- 380 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2004to Aug 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with treated diabetes mellitus undergoing surgery with major risk or patients with treated diabetes mellitus and known coronary artery disease undergoing surgery with major or intermediate risk
Who may be able to join
- diabetes mellitus with insulin or oral antidiabetics
- proven coronary artery disease or very high risk for it
- major non-vascular surgery
Who cannot join
- emergency
- no consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison in Survival in Patients With Insulin-dependent and Non-insulin-dependent Diabetes Mellitus With Known or Suspected Coronary Artery Disease Undergoing Major Non-cardiac Surgery
Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.
Read the detailed description
Diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. Patients with CAD have a worse prognosis if they have diabetes mellitus. But it is not known whether the treatment of Dm has an influence on mortality or morbidity.
In face of the high number of patients with Dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in Patients with Dm undergoing major non-vascular surgery. Inclusion criteria are medically treated Dm (insulin or oral antidiabetics) and major non cardiac surgery.
The "normal" perioperative treatment of the study is not changed by the study itself.
- Keywords
- insulin-dependent diabetes mellitus, non-insulin-dependent diabetes mellitus, coronary artery disease, long-term mortality
- Medical subject headings
- Diabetes Mellitus, Coronary Disease, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Death and/or major adverse cardiac events
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startJan 2004
- Primary completionAug 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bolliger, University Hospital, Basel, Switzerland
- Investigators
- Miodrag Filipovic, PD Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286572
- Sponsor's protocol ID
- 129/03
- Status last verified
- Mar 2015
- First submitted
- 2 Feb 2006
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in Survival in Patients With Insulin-dependent and Non-insulin-dependent Diabetes Mellitus With Known or Suspected Coronary Artery Disease Undergoing Major Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT00286572
- Acronym / sponsor ID
- 129/03
- Keywords
- insulin-dependent diabetes mellitus, non-insulin-dependent diabetes mellitus, coronary artery disease, long-term mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Feb 2006 (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.
Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.
Detailed description
Diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. Patients with CAD have a worse prognosis if they have diabetes mellitus. But it is not known whether the treatment of Dm has an influence on mortality or morbidity.
In face of the high number of patients with Dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in Patients with Dm undergoing major non-vascular surgery. Inclusion criteria are medically treated Dm (insulin or oral antidiabetics) and major non cardiac surgery.
The "normal" perioperative treatment of the study is not changed by the study itself.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with treated diabetes mellitus undergoing surgery with major risk or patients with treated diabetes mellitus and known coronary artery disease undergoing surgery with major or intermediate risk
Key inclusion criteria (3 listed)
- diabetes mellitus with insulin or oral antidiabetics
- proven coronary artery disease or very high risk for it
- major non-vascular surgery
Key exclusion criteria (2 listed)
- emergency
- no 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
Death and/or major adverse cardiac events
Time frame: 12 months after surgery
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 10 Mar 2015.
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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.
Miodrag Filipovic, PD Dr. principal investigator
University Hospital, Basel, Switzerland
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 Diabetes Mellitus and Coronary Heart Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 2 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 10 Mar 2015. 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 Switzerland. 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?
Death and/or major adverse cardiac events (time frame: 12 months after surgery). 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 10 Mar 2015.