Prediabetes or DiabetesNCT07662980
The Prevalence of Hyperglycemia in Surgical Patients With Pre-diabetes
An observational study of Prediabetes or Diabetes and Surgery Complications, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this study is to measure the prevalence and risks of hyperglycemia in surgical patients with prediabetes. The main questions it aims to answer are: What is the prevalence of hyperglycemia in surgical patients with prediabetes? What is the relative risk of postoperative complications associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes or Diabetes, Surgery Complications, Non-Cardiac/ Non-Thoracic Surgery
- How many people
- 750 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2027to 1 May 2028
- How long will I take part?
- 30 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Surgical in-patients at the Foothills Medical Centre.
Who may be able to join
- Hemoglobin A1c measurement between 6 and 6.4%
- Scheduled for non-cardiac surgery
Who cannot join
- Age>18
- Pregnancy
- Any formal diabetes diagnosis
- Current use of medications that influence blood glucose regardless of the indication
- Undergoing cardiac, intracranial neurosurgery, bariatric, or pancreatic surgeries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this study is to measure the prevalence and risks of hyperglycemia in surgical patients with prediabetes. The main questions it aims to answer are:
- What is the prevalence of hyperglycemia in surgical patients with prediabetes?
- What is the relative risk of postoperative complications associated with hyperglycemia?
To answer these questions, surgical patients with prediabetes will undergo universal glucose measurement in the perioperative period. Glucose data will be analyzed in conjunction with electronic health record (EHR) data describing patient outcomes.
Read the detailed description
Background
Day-of-surgery and postoperative ('perioperative') hyperglycemia are modifiable risk factors for complications after non-cardiac surgery, including surgical site infections, 30-day readmissions, and mortality. Data from Alberta suggests perioperative hyperglycemia is common among people without diabetes, affecting about 13% of people with prediabetes on the day-of-surgery and 18% of people without diabetes after surgery. Paradoxically, the risks of perioperative hyperglycemia appear to be two-times greater for people with prediabetes than for people with diabetes and the reasons for this are unknown. Current estimates of the prevalence of perioperative for people with prediabetes are limited. Understanding the true prevalence would inform individual decision-making around surgery, the need for further research about the true association of hyperglycemia and adverse outcomes, and clinical decisions about the utility of measuring glucose for all people with prediabetes around the time of surgery.
Objectives
This prospective cohort study will establish the prevalence of perioperativehyperglycemia in people with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries. This information will inform:
- Patients, to better understand their individual risks of elective surgery.
- Clinicians, on the need for perioperative glucose measurement for patients with prediabetes.
- Researchers, on the need for and design of further studies.
Methods Overview
We will measure glucose in all adult patients with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries throughout the perioperative period (referring to the day of surgery and up to the first 3 postoperative days or discharge, whichever comes first) to determine the prevalence of perioperative dysglycemia in people with prediabetes.
This project will leverage established data sources and linkages to address secondary and exploratory objectives: (1) Use in-hospital insulin prescribing data to describe current practices for treatment of perioperative hyperglycemia in people with prediabetes; (2) Explore the association between clinical outcomes like infections and length of stay with perioperative hyperglycemia in people with prediabetes; and (3) Compare the prevalence of perioperative hyperglycemia and the association of hyperglycemia with clinical outcomes between the intervention period and a historical control period (pre-intervention at the same hospital) and a contemporaneous, non-intervention site (UAH, Edmonton) to examine whether the 'prediabetes paradox' is a result of confounding by indication or another cause.
Outcomes
If the prevalence of perioperative hyperglycemia in people with prediabetes is sufficiently high, clinical guidelines should recommend perioperative glycemic monitoring for patients with prediabetes. Further, if there is an association between hyperglycemia and adverse outcomes, intervention-based studies are needed to determine whether this risk is modifiable with hyperglycemia treatment.
Team
The NPI and co-investigators have led a 5-year implementation science and quality improvement study to improve perioperative glycemic management for people with diabetes in Alberta. This interdisciplinary group of patients, nurses, endocrinologists, surgeons, anesthesiologists, internists, and implementation scientists will leverage their existing data access, professional networks, and content expertise to conduct this study.
- Conditions
- Prediabetes or Diabetes, Surgery Complications, Non-Cardiac/ Non-Thoracic Surgery, Stress Hyperglycemia
- Keywords
- Prediabetes, Prevalence, Surgical Complications, Perioperative Hyperglycemia
- Medical subject headings
- Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Patients with Prediabetes | Adult patients undergoing non-cardiac surgeries who have pre-diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of perioperative hyperglycemia
Prediabetes will be defined as described in Section 4.2 using Diabetes Canada definitions. The perioperative period will include the day of surgery and the early postoperative period. The day of surgery includes surgical admitting, intraoperative, and recovery room on postoperative day (POD) 0, which is the day that surgery was completed until 23:59. The early postoperative period will be defined as the first 3 full postoperative days, in keeping with studies that have demonstrated that hyperglycemia is most common in the first 72 hours after surgery and that early hyperglycemia is associated with greater 30-day postoperative mortality. Hyperglycemia will be defined using Diabetes Canada reference ranges as any glucose value >10.0 mmol/L by any form of glucose measurement.
Measured: Up to the first 3 postoperative days or discharge, whichever comes first.
Secondary outcomes (1)
Post-operative complications
Postoperative complications are defined in accordance with the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), a standardized list of preventable complications developed by surgeons and used internationally to describe hospital-level quality of surgical care. These include the following adverse events within 30 days of surgery: SSIs (superficial, deep incisional, organ/space, using the Centres for Disease Control definitions), wound dehiscence, pneumonia, unplanned intubation, pulmonary embolism, ventilator use >48 hours, acute renal failure, urinary tract infection, stroke, cardiac arrest, myocardial infarction, transfusion complications, deep vein thrombosis, sepsis, septic shock, Clostridium difficile infection, death, readmissions, and unplanned reoperations.
Measured: Within 30 days of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 May 2027 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (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 Prediabetes or DiabetesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 750 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Ruzycki, University of Calgary
- Investigators
- Shannon Ruzycki, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662980
- Sponsor's protocol ID
- REB26-0116
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD, specifically deidentified patient data will be shared upon reasonable request by fellow research teams.
Publications
Ruzycki SM, Harrison TG, Lithgow KC, Cameron A, Philp L, Heatlie L, Esmail R, Ejaredar M, Helmle K, McKeen J, Dillane D. Day-of-surgery quality gaps in glycemic management: a retrospective cohort study. Perioper Med (Lond). 2025 Nov 25;14(1):143. doi: 10.1186/s13741-025-00628-3.
PubMed 41291884
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Hyperglycemia in Surgical Patients With Pre-diabetes
- ClinicalTrials.gov ID
- NCT07662980
- Acronym / sponsor ID
- REB26-0116
- Conditions
- Prediabetes or Diabetes, Surgery Complications, Non-Cardiac/ Non-Thoracic Surgery, Stress Hyperglycemia
- Keywords
- Prediabetes, Prevalence, Surgical Complications, Perioperative Hyperglycemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Jun 2026 (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.
The goal of this study is to measure the prevalence and risks of hyperglycemia in surgical patients with prediabetes. The main questions it aims to answer are:
- What is the prevalence of hyperglycemia in surgical patients with prediabetes?
- What is the relative risk of postoperative complications associated with hyperglycemia?
To answer these questions, surgical patients with prediabetes will undergo universal glucose measurement in the perioperative period. Glucose data will be analyzed in conjunction with electronic health record (EHR) data describing patient outcomes.
Detailed description
Background
Day-of-surgery and postoperative ('perioperative') hyperglycemia are modifiable risk factors for complications after non-cardiac surgery, including surgical site infections, 30-day readmissions, and mortality. Data from Alberta suggests perioperative hyperglycemia is common among people without diabetes, affecting about 13% of people with prediabetes on the day-of-surgery and 18% of people without diabetes after surgery. Paradoxically, the risks of perioperative hyperglycemia appear to be two-times greater for people with prediabetes than for people with diabetes and the reasons for this are unknown. Current estimates of the prevalence of perioperative for people with prediabetes are limited. Understanding the true prevalence would inform individual decision-making around surgery, the need for further research about the true association of hyperglycemia and adverse outcomes, and clinical decisions about the utility of measuring glucose for all people with prediabetes around the time of surgery.
Objectives
This prospective cohort study will establish the prevalence of perioperativehyperglycemia in people with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries. This information will inform:
- Patients, to better understand their individual risks of elective surgery.
- Clinicians, on the need for perioperative glucose measurement for patients with prediabetes.
- Researchers, on the need for and design of further studies.
Methods Overview
We will measure glucose in all adult patients with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries throughout the perioperative period (referring to the day of surgery and up to the first 3 postoperative days or discharge, whichever comes first) to determine the prevalence of perioperative dysglycemia in people with prediabetes.
This project will leverage established data sources and linkages to address secondary and exploratory objectives: (1) Use in-hospital insulin prescribing data to describe current practices for treatment of perioperative hyperglycemia in people with prediabetes; (2) Explore the association between clinical outcomes like infections and length of stay with perioperative hyperglycemia in people with prediabetes; and (3) Compare the prevalence of perioperative hyperglycemia and the association of hyperglycemia with clinical outcomes between the intervention period and a historical control period (pre-intervention at the same hospital) and a contemporaneous, non-intervention site (UAH, Edmonton) to examine whether the 'prediabetes paradox' is a result of confounding by indication or another cause.
Outcomes
If the prevalence of perioperative hyperglycemia in people with prediabetes is sufficiently high, clinical guidelines should recommend perioperative glycemic monitoring for patients with prediabetes. Further, if there is an association between hyperglycemia and adverse outcomes, intervention-based studies are needed to determine whether this risk is modifiable with hyperglycemia treatment.
Team
The NPI and co-investigators have led a 5-year implementation science and quality improvement study to improve perioperative glycemic management for people with diabetes in Alberta. This interdisciplinary group of patients, nurses, endocrinologists, surgeons, anesthesiologists, internists, and implementation scientists will leverage their existing data access, professional networks, and content expertise to conduct this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients with Prediabetes | – | –Adult patients undergoing non-cardiac surgeries who have pre-diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical in-patients at the Foothills Medical Centre.
Key inclusion criteria (2 listed)
- Hemoglobin A1c measurement between 6 and 6.4%
- Scheduled for non-cardiac surgery
Key exclusion criteria (5 listed)
- Age>18
- Pregnancy
- Any formal diabetes diagnosis
- Current use of medications that influence blood glucose regardless of the indication
- Undergoing cardiac, intracranial neurosurgery, bariatric, or pancreatic surgeries
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
Prevalence of perioperative hyperglycemia
Time frame: Up to the first 3 postoperative days or discharge, whichever comes first.
Prediabetes will be defined as described in Section 4.2 using Diabetes Canada definitions. The perioperative period will include the day of surgery and the early postoperative period. The day of surgery includes surgical admitting, intraoperative, and recovery room on postoperative day (POD) 0, which is the day that surgery was completed until 23:59. The early postoperative period will be defined as the first 3 full postoperative days, in keeping with studies that have demonstrated that hyperglycemia is most common in the first 72 hours after surgery and that early hyperglycemia is associated with greater 30-day postoperative mortality. Hyperglycemia will be defined using Diabetes Canada reference ranges as any glucose value >10.0 mmol/L by any form of glucose measurement.
1 secondary outcome
Post-operative complications
Time frame: Within 30 days of surgery.
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 23 Jun 2026.
- Background: PubMed 41291884Ruzycki SM, Harrison TG, Lithgow KC, Cameron A, Philp L, Heatlie L, Esmail R, Ejaredar M, Helmle K, McKeen J, Dillane D. Day-of-surgery quality gaps in glycemic management: a retrospective cohort study. Perioper Med (Lond). 2025 Nov 25;14(1):143. doi: 10.1186/s13741-025-00628-3.
- This website describes the processes outlined a prior quality improvement project designed and implemented by our team. This study follows similar through lines to the present study, as we will be using the same systems and personnel.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD, specifically deidentified patient data will be shared upon reasonable request by fellow research teams.
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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.
Shannon Ruzycki, MD principal investigator
University of Calgary
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 Prediabetes or Diabetes and Surgery Complications, run by University of Calgary 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 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: opening soon, as of the sponsor's last update on 23 Jun 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?
Contact Shannon Ruzycki, MD (+1 (403) 604-1642, shannon.ruzycki@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of perioperative hyperglycemia (time frame: Up to the first 3 postoperative days or discharge, whichever comes first.). 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 NCT07662980, 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 23 Jun 2026.