DiabetesNCT06589466
Preoperative Optimization of Diabetic Patients
An observational study of Diabetes and Surgery Related Complications Rate, run by University of Alberta at 1 site in Canada.
Trial summary
Diabetic patients, as part of preoperative evaluation, should have glycated hemoglobin (HbA1C) measured. HbA1C provides information on longterm glucose control. There is a suggestion in the literature that elevated A1C levels predict a higher rate of postoperative adverse events, including infections, myocardial… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Surgery Related Complications Rate
- What is being tested?
- Surgery
- How many people
- 46,000 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jan 2025to 31 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Adults having any surgical procedure at any hospital in Alberta
Who may be able to join
- Age 18 or greater
- Having any surgical procedure at any hospital in Alberta
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Review of Preoperative Optimization of Diabetic Patients
Diabetic patients, as part of preoperative evaluation, should have glycated hemoglobin (HbA1C) measured. HbA1C provides information on longterm glucose control. There is a suggestion in the literature that elevated A1C levels predict a higher rate of postoperative adverse events, including infections, myocardial infarction, and mortality. It is unclear whether chronic glycemia, as reflected in raised HbA1C level, is the risk factor for adverse perioperative events or whether it is a surrogate measure for poor perioperative glucose management. Conversely, in a retrospective analysis of 431,480 surgeries perioperative glucose was predictive of increased 30-day mortality, but that HbA1C was a less useful predictor of this measure. In our experience of at the University of Alberta Preadmission Clinic there is significant variability with respect to whether diabetic patients have a valid HbA1C measurement i.e. within 3 months of surgery. If a valid measurement is present, there is also considerable variability with respect to diabetes control.
Read the detailed description
Purpose: The purpose of this study to retrospectively determine the incidence of diabetes in the surgical population and what proportion of diabetic patients have a valid HbA1C. Hypothesis: A valid (measured within 3 months of surgery) HbA1C measurement is frequently missing prior to surgery and when present has a high chance of being higher than normal.
Objectives:
Perform a retrospective analysis of all surgeries in Alberta from November 2019 to the present time looking for the following:
Primary outcomes:
- Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients
- Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
- Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
Secondary outcomes:
- Determine association between HbA1C and post-operative length of stay
- Determine association between HbA1C and in hospital mortality Design: This study will be a population-based, retrospective observational cohort study. Setting: Alberta Hospitals Participants: Adults with diabetes having surgery in Alberta since November 2019 Descriptive statistics will be tabulated according to HbA1C status and Univariate comparisons of means, medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes. Normally distributed continuous data will be reported as means with standard deviations (SD). Non-normally distributed continuous data will be reported as medians with interquartile ranges (IQR). Categorical variables will be compared using Chi-square test for independence
- Conditions
- Diabetes, Surgery Related Complications Rate
- Being tested
- Surgery
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
this study in observational study, no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Adults with diabetes having surgery in Alberta since November 2019 | Adults with diabetes having surgery in Alberta since November 2019 Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevelance of diabetes among surgical population
Determine the incidence of diabetes in the surgical population
Measured: 11/2019-12/2023
HB1AC measuerment in diabetic patients
Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
Measured: 11/2019-12/2023
Long term diabetes control among surgical patients
Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
Measured: 11/2019-12/2023
Secondary outcomes (2)
In hospital mortality
Determine association between HbA1C and in hospital mortality
Measured: 11/2019-12/2023
Post-operative length of stay
Determine association between HbA1C and post-operative length of stay
Measured: 11/2019-12/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Other
- Time perspective
- Other
- Enrolment
- 46,000 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589466
- Sponsor's protocol ID
- Pro00139994
- Status last verified
- May 2026
- First submitted
- 5 Sep 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team still debating sharing the IPD
Publications
Dronge AS, Perkal MF, Kancir S, Concato J, Aslan M, Rosenthal RA. Long-term glycemic control and postoperative infectious complications. Arch Surg. 2006 Apr;141(4):375-80; discussion 380. doi: 10.1001/archsurg.141.4.375.
PubMed 16618895Jones CE, Graham LA, Morris MS, Richman JS, Hollis RH, Wahl TS, Copeland LA, Burns EA, Itani KMF, Hawn MT. Association Between Preoperative Hemoglobin A1c Levels, Postoperative Hyperglycemia, and Readmissions Following Gastrointestinal Surgery. JAMA Surg. 2017 Nov 1;152(11):1031-1038. doi: 10.1001/jamasurg.2017.2350.
PubMed 28746706Stryker LS, Abdel MP, Morrey ME, Morrow MM, Kor DJ, Morrey BF. Elevated postoperative blood glucose and preoperative hemoglobin A1C are associated with increased wound complications following total joint arthroplasty. J Bone Joint Surg Am. 2013 May 1;95(9):808-14, S1-2. doi: 10.2106/JBJS.L.00494.
PubMed 23636187van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB. Effect of A1C and Glucose on Postoperative Mortality in Noncardiac and Cardiac Surgeries. Diabetes Care. 2018 Apr;41(4):782-788. doi: 10.2337/dc17-2232. Epub 2018 Feb 13.
PubMed 29440113
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Preoperative Optimization of Diabetic Patients
- ClinicalTrials.gov ID
- NCT06589466
- Acronym / sponsor ID
- Pro00139994
- Conditions
- Diabetes, Surgery Related Complications Rate
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 46,000 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Diabetic patients, as part of preoperative evaluation, should have glycated hemoglobin (HbA1C) measured. HbA1C provides information on longterm glucose control. There is a suggestion in the literature that elevated A1C levels predict a higher rate of postoperative adverse events, including infections, myocardial infarction, and mortality. It is unclear whether chronic glycemia, as reflected in raised HbA1C level, is the risk factor for adverse perioperative events or whether it is a surrogate measure for poor perioperative glucose management. Conversely, in a retrospective analysis of 431,480 surgeries perioperative glucose was predictive of increased 30-day mortality, but that HbA1C was a less useful predictor of this measure. In our experience of at the University of Alberta Preadmission Clinic there is significant variability with respect to whether diabetic patients have a valid HbA1C measurement i.e. within 3 months of surgery. If a valid measurement is present, there is also considerable variability with respect to diabetes control.
Detailed description
Purpose: The purpose of this study to retrospectively determine the incidence of diabetes in the surgical population and what proportion of diabetic patients have a valid HbA1C. Hypothesis: A valid (measured within 3 months of surgery) HbA1C measurement is frequently missing prior to surgery and when present has a high chance of being higher than normal.
Objectives:
Perform a retrospective analysis of all surgeries in Alberta from November 2019 to the present time looking for the following:
Primary outcomes:
- Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients
- Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
- Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
Secondary outcomes:
- Determine association between HbA1C and post-operative length of stay
- Determine association between HbA1C and in hospital mortality Design: This study will be a population-based, retrospective observational cohort study. Setting: Alberta Hospitals Participants: Adults with diabetes having surgery in Alberta since November 2019 Descriptive statistics will be tabulated according to HbA1C status and Univariate comparisons of means, medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes. Normally distributed continuous data will be reported as means with standard deviations (SD). Non-normally distributed continuous data will be reported as medians with interquartile ranges (IQR). Categorical variables will be compared using Chi-square test for independence
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with diabetes having surgery in Alberta since November 2019 | – | Other: SurgeryAdults with diabetes having surgery in Alberta since November 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Adults having any surgical procedure at any hospital in Alberta
Key inclusion criteria (2 listed)
- Age 18 or greater
- Having any surgical procedure at any hospital in Alberta
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Surgerythis study in observational study, no intervention. | Other | Adults with diabetes having surgery in Alberta since November 2019 |
Primary outcome
Prevelance of diabetes among surgical population
Time frame: 11/2019-12/2023
Determine the incidence of diabetes in the surgical population
HB1AC measuerment in diabetic patients
Time frame: 11/2019-12/2023
Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
Long term diabetes control among surgical patients
Time frame: 11/2019-12/2023
Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery
2 secondary outcomes
In hospital mortality
Time frame: 11/2019-12/2023
Post-operative length of stay
Time frame: 11/2019-12/2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 16618895Dronge AS, Perkal MF, Kancir S, Concato J, Aslan M, Rosenthal RA. Long-term glycemic control and postoperative infectious complications. Arch Surg. 2006 Apr;141(4):375-80; discussion 380. doi: 10.1001/archsurg.141.4.375.
- Background: PubMed 28746706Jones CE, Graham LA, Morris MS, Richman JS, Hollis RH, Wahl TS, Copeland LA, Burns EA, Itani KMF, Hawn MT. Association Between Preoperative Hemoglobin A1c Levels, Postoperative Hyperglycemia, and Readmissions Following Gastrointestinal Surgery. JAMA Surg. 2017 Nov 1;152(11):1031-1038. doi: 10.1001/jamasurg.2017.2350.
- Background: PubMed 23636187Stryker LS, Abdel MP, Morrey ME, Morrow MM, Kor DJ, Morrey BF. Elevated postoperative blood glucose and preoperative hemoglobin A1C are associated with increased wound complications following total joint arthroplasty. J Bone Joint Surg Am. 2013 May 1;95(9):808-14, S1-2. doi: 10.2106/JBJS.L.00494.
- Background: PubMed 29440113van den Boom W, Schroeder RA, Manning MW, Setji TL, Fiestan GO, Dunson DB. Effect of A1C and Glucose on Postoperative Mortality in Noncardiac and Cardiac Surgeries. Diabetes Care. 2018 Apr;41(4):782-788. doi: 10.2337/dc17-2232. Epub 2018 Feb 13.
- Individual participant dataSharing planned: Undecided. The study team still debating sharing the IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Surgery Related Complications Rate, run by University of Alberta at 1 site in Canada.
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 0 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevelance of diabetes among surgical population (time frame: 11/2019-12/2023). The study lists 3 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 NCT06589466, which also lists 4 linked publications.
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 May 2026.