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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

NCTNCT04862234 (opens ClinicalTrials.gov in a new tab)Other idIRB00097659Other idK23DK122199
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
16 participants (actual)
Sponsor
Emory University · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
6 Aug 2021
Primary completion
22 Jun 2023
Completion
22 Jun 2023
First posted
27 Apr 2021
Last update posted
17 Jan 2025
Conditions
Hyperglycemia Stress

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 4

    Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

    NCT04862234

    6 Aug 2021 to 22 Jun 2023

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Hyperglycemia is seen in approximately 30% of patients who do not have a history of diabetes and undergo general surgery. Hyperglycemia in this setting is associated with increased risk of postoperative complications. The purpose of this study is to investigate risk factors for developing high sugars during the time of surgery, and if these high sugars can be prevented by the use of an injectable diabetes medication (dulaglutide) prior to surgery.

Interventions

  • DulaglutideDrug
  • PlaceboDrug
  • Continuous glucose monitor (CGM), blindedDevice

Arms2

  • Experimental

    Dulaglutide

    Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.

  • Placebo comparator

    Placebo

    Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The percentage of time in the target glucose range of 70-140 mg/dL, as measured by a continuous glucose monitor (CGM) data was determined.

Secondary outcomes(16)

  1. Percentage of Time in Hyperglycemia (Glucose>140 mg/dL)

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The percentage of time in hyperglycemia with glucose\>140 mg/dL will be examined.

  2. Percentage of Time in Hyperglycemia (Glucose>180 mg/dL)

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The percentage of time in hyperglycemia with glucose\>180 mg/dL will be examined.

  3. Percentage of Time in Hypoglycemia (Glucose <70 mg/dL)

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The percentage of time in hypoglycemia with glucose \<70 mg/dL will be examined.

  4. Percentage of Time in Hypoglycemia (Glucose <54 mg/dL)

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The percentage of time in hypoglycemia with glucose \<54 mg/dL will be examined.

  5. Percentage of Time in Hypoglycemia (Glucose <40 mg/dL)

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The percentage of time in hypoglycemia with glucose \<40 mg/dL will be examined.

  6. Mean Onset of Stress Hyperglycemia During the Postoperative Period

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The mean onset time of stress hyperglycemia during the postoperative period by CGM data will be examined.

  7. Mean Duration of Stress Hyperglycemia During the Postoperative Period

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The mean duration of stress hyperglycemia during the postoperative period by CGM data will be examined.

  8. Mean Daily Glucose Values

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The mean daily glucose values, as measured by both point of care (POC) glucose testing and CGM data, will be examined.

  9. Maximum Daily Glucose Values

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    The maximum daily glucose values, as measured by both POC glucose testing and CGM data, will be examined.

  10. Perioperative Insulin Requirements

    Time frame · During hospitalization (up to 5 days postoperatively)

    Registry description

    Perioperative insulin requirements will be assessed as the total daily insulin dose.

  11. Change in Plasma Cortisol Level

    Time frame · Baseline, 48 to 72 hours postoperatively

    Registry description

    Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

  12. Change in Level of Free Fatty Acids (FFA)

    Time frame · Baseline, 48 to 72 hours postoperatively

    Registry description

    Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

  13. Change in High Sensitivity C-reactive Protein (hsCRP) Level

    Time frame · Baseline, 48 to 72 hours postoperatively

    Registry description

    Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

  14. Change in Tumor Necrosis Factor-alpha (TNF-α) Level

    Time frame · Baseline, 48 to 72 hours postoperatively

    Registry description

    Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

  15. Change in Adiponectin Level

    Time frame · Baseline, 48 to 72 hours postoperatively

    Registry description

    Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

  16. Change in Level of Thiobarbituric Acid Reactive Substances (TBARS)

    Time frame · Baseline, 48 to 72 hours postoperatively

    Registry description

    Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· During hospitalization (up to 5 days postoperatively)

Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM

GroupValue (percentage of time)Spread
Dulaglutide84.1919.70
Placebo71.8227.26
Secondary and other outcome results(7)
Secondary outcome· During hospitalization (up to 5 days postoperatively)

Percentage of Time in Hyperglycemia (Glucose>140 mg/dL)

GroupValue
Secondary outcome· During hospitalization (up to 5 days postoperatively)

Percentage of Time in Hyperglycemia (Glucose>180 mg/dL)

GroupValue
Secondary outcome· During hospitalization (up to 5 days postoperatively)

Percentage of Time in Hypoglycemia (Glucose <70 mg/dL)

GroupValue
Secondary outcome· During hospitalization (up to 5 days postoperatively)

Percentage of Time in Hypoglycemia (Glucose <54 mg/dL)

GroupValue
Secondary outcome· During hospitalization (up to 5 days postoperatively)

Percentage of Time in Hypoglycemia (Glucose <40 mg/dL)

GroupValue
Secondary outcome· During hospitalization (up to 5 days postoperatively)

Mean Onset of Stress Hyperglycemia During the Postoperative Period

GroupValue
Secondary outcome· During hospitalization (up to 5 days postoperatively)

Mean Duration of Stress Hyperglycemia During the Postoperative Period

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DulaglutideParticipants randomized to receive dulaglutide within 72 hours prior to a planned surgery.0 / 81 / 83 / 8
PlaceboParticipants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.0 / 80 / 82 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 45 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: * Men and women without known history of diabetes with ages between 45 and 80 years undergoing non-cardiac general or vascular surgery * BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c Exclusion criteria: * Patients prescribed or taking antihyperglycemic medications * Patients undergoing cardiac surgery or patients anticipated to require ICU care * Patients expected to be admitted less than 48-72 hours after surgery * Severely impaired renal function (eGFR \< 30 mL/min) or clinically significant hepatic failure * Treatment with oral (equivalent to prednisone \> 5 mg/day) or injectable corticosteroids * Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; unable to consent * Pregnant or breast feeding at time of enrollment * Prisoners * Patients undergoing gastrointestinal surgery or at high risk for gastrointestinal obstruction/ileus or expected to require gastrointestinal suction * Patients with delayed gastric emptying, pancreatic or gallbladder disease * Patients with personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)

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