Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

The Prevalence of Hyperglycemia in Surgical Patients With Pre-diabetes

17 juni 2026 bijgewerkt door: Shannon Ruzycki, University of Calgary

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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:

  1. Patients, to better understand their individual risks of elective surgery.
  2. Clinicians, on the need for perioperative glucose measurement for patients with prediabetes.
  3. 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.

Studietype

Observationeel

Inschrijving (Geschat)

750

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Centre

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Surgical in-patients at the Foothills Medical Centre.

Beschrijving

Inclusion Criteria:

  • Hemoglobin A1c measurement between 6 and 6.4%
  • Scheduled for non-cardiac surgery

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Surgical Patients with Prediabetes
Adult patients undergoing non-cardiac surgeries who have pre-diabetes.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Prevalence of perioperative hyperglycemia
Tijdsspanne: 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.
Up to the first 3 postoperative days or discharge, whichever comes first.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Post-operative complications
Tijdsspanne: Within 30 days of surgery.
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.
Within 30 days of surgery.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Calgary

Onderzoekers

  • Hoofdonderzoeker: Shannon Ruzycki, MD, University Of Calgary

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2027

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

23 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juni 2026

Eerst geplaatst (Werkelijk)

23 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • REB26-0116

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

IPD, specifically deidentified patient data will be shared upon reasonable request by fellow research teams.

IPD-tijdsbestek voor delen

Data will be available after analyses have completed, approximately in the month of March, 2028. Data will be retained in accordance with the University of Calgary's Master Records Retention Schedule(MaRRS). During this time period, data will be available upon reasonable request.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren