NCT06589466

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

September 5, 2024

Last Update Submit

May 4, 2026

Conditions

DiabetesSurgery Related Complications Rate

Outcome Measures

Primary Outcomes (3)

  • Prevelance of diabetes among surgical population

    Determine the incidence of diabetes in the surgical population

    11/2019-12/2023

  • HB1AC measuerment in diabetic patients

    Determine the incidence of valid HbA1C in diabetic patients presenting for surgery

    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

    11/2019-12/2023

Secondary Outcomes (2)

  • In hospital mortality

    11/2019-12/2023

  • Post-operative length of stay

    11/2019-12/2023

Study Arms (1)

Adults with diabetes having surgery in Alberta since November 2019

Adults with diabetes having surgery in Alberta since November 2019

Other: Surgery

Interventions

SurgeryOTHER

this study in observational study, no intervention.

Adults with diabetes having surgery in Alberta since November 2019

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Adults having any surgical procedure at any hospital in Alberta

You may qualify if:

  • Age 18 or greater
  • Having any surgical procedure at any hospital in Alberta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

Location

Related Publications (4)

  • 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.

    PMID: 16618895BACKGROUND

  • Jones 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.

    PMID: 28746706BACKGROUND

  • Stryker 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.

    PMID: 23636187BACKGROUND

  • van 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.

    PMID: 29440113BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

January 22, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

CA(1)