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Active, Not Recruiting

NCT Number: NCT06589466

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Surgery Related Complications Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

SURGERY

Other

this study in observational study, no intervention.

Primary outcomes

  1. Prevelance of diabetes among surgical population

    Time frame: 11/2019-12/2023

    Determine the incidence of diabetes in the surgical population

  2. HB1AC measuerment in diabetic patients

    Time frame: 11/2019-12/2023

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

  3. 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

Secondary outcomes

  1. In hospital mortality

    Time frame: 11/2019-12/2023

    Determine association between HbA1C and in hospital mortality

  2. Post-operative length of stay

    Time frame: 11/2019-12/2023

    Determine association between HbA1C and post-operative length of stay

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Retrospective Review of Preoperative Optimization of Diabetic Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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