Diabetes MellitusNCT03967639
Seasonal Trends of Respiratory Morbidity in Diabetic Patients
An observational study of Diabetes Mellitus and Respiratory Complication, run by Szeged University at 1 site in Hungary.
Trial summary
Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Respiratory Complication, Perioperative/Postoperative Complications
- What is being tested?
- Elective cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 9,838 participants
- Where
- 1 siteHungary
- Study dates
- 1 Feb 2019to Dec 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged
Who may be able to join
- all patients undergoing cardiac surgery with or without diabetes mellitus, age between 18-85 years during the time period January 2007 to December 2018
Who cannot join
- patients older than 85 years
- patients younger than 18 years
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Cardiology Centre Cardiac Surgical Unit and Second Department of Internal Medicine, University of Szeged
Szeged, Csongrád megye, 6725
About this study
Official title: Retrospective Analysis of Seasonal Trends of Respiratory Morbidity in Diabetic Patients
Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate respiratory mechanics.
Therefore, the study is aimed at a retrospective analysis of seasonal trends in respiratory consequences of T2DM, i.e.: i: distribution of patients with and without T2DM presenting for elective cardiac surgery during the two-year examination period; ii: characterization of respiratory co-morbidities in the patients, iii: exploring whether the respiratory mechanics at presentation and those caused by cardiac surgery exhibit different trends in T2DM and control patients.
Read the detailed description
Our study is a retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged.
Electronic and paper documentation will be examined and anonymously analysed for the following information:
- date of cardiac surgery,
- type of cardiac surgery procedure,
- demographic data (age, height, weight),
- presence of T2DM (previous diagnosis, fasting plasma glucose level, glycated haemoglobin [HbA1C]),
- presence of respiratory co-morbidities (e.g. asthma, COPD, etc.),
- presence of other circulatory co-mobidities (e.g. hypertension, previous stroke, vascular stenosis)
- respiratory mechanical parameters before and after cardiac surgery, 7. presence of perioperative respiratory complications, 8. history of smoking 9. blood gas measurements before, during and after surgery
Time series statistical analysis of all data will be carried out to discover the presence of seasonal trends in both diabetic and control patients. Analysis of variance (ANOVA) will be carried out to explore global differences between diabetic and control patients.
- Being tested
- Elective cardiac surgery
- Keywords
- cardiac surgical procedures, respiratory mechanics, seasonal variation
- Medical subject headings
- Diabetes Mellitus, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective cardiac surgeryProcedure or surgery
Elective cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Group T2DM | Patients with diabetes mellitus undergoing elective cardiac surgery Receives: Procedure: Elective cardiac surgery | |
| Group Ctrl | Control patients undergoing elective cardiac surgery without T2DM Receives: Procedure: Elective cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seasonal variation in the incidence of diabetic patients undergoing cardiac surgery
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting.
The relative incidence of diabetic patients will be evaluated on a monthly basis in the study period.
Measured: Retrospective data analysis (2006-2018)
Anthropometric data of patients undergoing cardiac surgery
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting.
Anthropometric data will be collected from the patient records: height (meters) and weight (kilograms) of each patient will be collected from the hospital medical records, then these data will be combined to report BMI (kg/m^2).
Measured: Retrospective data analysis (2006-2018)
Comorbidities of diabetic patients undergoing cardiac surgery
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting.
Co-morbidities (COPD, asthma, hypertension, etc.) of each patient will be collected from the hospital medical records.
Measured: Retrospective data analysis (2006-2018)
Smoking habits of patients undergoing cardiac surgery
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting.
Reported smoking habits (present smoker/previous smoker/never smoker; number of packs / day; duration) of each patient will be collected from the hospital medical records.
Measured: Retrospective data analysis (2006-2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Feb 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9,838 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Collaborators
- Hungarian Basic Research Council, GINOP
- Responsible party
- Principal investigator, Barna Babik, Szeged University
- Investigators
- Barna Babik, MD, PhD, Principal investigator, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967639
- Sponsor's protocol ID
- WHO2788-c
- Status last verified
- May 2019
- First submitted
- 4 Feb 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Petak F, Kovacs BN, Agocs S, Virag K, Nyari T, Molnar A, Sudy R, Lengyel C, Babik B. Seasonal changes in proportion of cardiac surgeries associated with diabetes, smoking and elderly age. PLoS One. 2022 Sep 22;17(9):e0274105. doi: 10.1371/journal.pone.0274105. eCollection 2022.
PubMed 36136994
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Seasonal Trends of Respiratory Morbidity in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03967639
- Acronym / sponsor ID
- WHO2788-c
- Keywords
- cardiac surgical procedures, respiratory mechanics, seasonal variation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,838 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Collaborators
- Hungarian Basic Research Council, GINOP
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 May 2019 (actual)
- 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.
Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate respiratory mechanics.
Therefore, the study is aimed at a retrospective analysis of seasonal trends in respiratory consequences of T2DM, i.e.: i: distribution of patients with and without T2DM presenting for elective cardiac surgery during the two-year examination period; ii: characterization of respiratory co-morbidities in the patients, iii: exploring whether the respiratory mechanics at presentation and those caused by cardiac surgery exhibit different trends in T2DM and control patients.
Detailed description
Our study is a retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged.
Electronic and paper documentation will be examined and anonymously analysed for the following information:
- date of cardiac surgery,
- type of cardiac surgery procedure,
- demographic data (age, height, weight),
- presence of T2DM (previous diagnosis, fasting plasma glucose level, glycated haemoglobin [HbA1C]),
- presence of respiratory co-morbidities (e.g. asthma, COPD, etc.),
- presence of other circulatory co-mobidities (e.g. hypertension, previous stroke, vascular stenosis)
- respiratory mechanical parameters before and after cardiac surgery, 7. presence of perioperative respiratory complications, 8. history of smoking 9. blood gas measurements before, during and after surgery
Time series statistical analysis of all data will be carried out to discover the presence of seasonal trends in both diabetic and control patients. Analysis of variance (ANOVA) will be carried out to explore global differences between diabetic and control patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T2DM | – | Procedure: Elective cardiac surgeryPatients with diabetes mellitus undergoing elective cardiac surgery |
| Group Ctrl | – | Procedure: Elective cardiac surgeryControl patients undergoing elective cardiac surgery without T2DM |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged
Key inclusion criteria (1 listed)
- all patients undergoing cardiac surgery with or without diabetes mellitus, age between 18-85 years during the time period January 2007 to December 2018
Key exclusion criteria (2 listed)
- patients older than 85 years
- patients younger than 18 years
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 |
|---|---|---|
| Elective cardiac surgeryElective cardiac surgery | Procedure or surgery | Group Ctrl, Group T2DM |
Primary outcome
Seasonal variation in the incidence of diabetic patients undergoing cardiac surgery
Time frame: Retrospective data analysis (2006-2018)
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. The relative incidence of diabetic patients will be evaluated on a monthly basis in the study period.
Anthropometric data of patients undergoing cardiac surgery
Time frame: Retrospective data analysis (2006-2018)
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Anthropometric data will be collected from the patient records: height (meters) and weight (kilograms) of each patient will be collected from the hospital medical records, then these data will be combined to report BMI (kg/m^2).
Comorbidities of diabetic patients undergoing cardiac surgery
Time frame: Retrospective data analysis (2006-2018)
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Co-morbidities (COPD, asthma, hypertension, etc.) of each patient will be collected from the hospital medical records.
Smoking habits of patients undergoing cardiac surgery
Time frame: Retrospective data analysis (2006-2018)
All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Reported smoking habits (present smoker/previous smoker/never smoker; number of packs / day; duration) of each patient will be collected from the hospital medical records.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Derived from this study: PubMed 36136994Petak F, Kovacs BN, Agocs S, Virag K, Nyari T, Molnar A, Sudy R, Lengyel C, Babik B. Seasonal changes in proportion of cardiac surgeries associated with diabetes, smoking and elderly age. PLoS One. 2022 Sep 22;17(9):e0274105. doi: 10.1371/journal.pone.0274105. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Barna Babik, MD, PhD principal investigator
Szeged University
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 Respiratory Complication, run by Szeged University at 1 site in Hungary.
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 1 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: status not confirmed, as of the sponsor's last update on 30 May 2019. 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 Hungary. 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?
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?
Seasonal variation in the incidence of diabetic patients undergoing cardiac surgery (time frame: Retrospective data analysis (2006-2018)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967639, which also lists 1 linked publication.
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 30 May 2019.