Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients
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.
Conditions:
🦠 Hyperglycemia Stress
🗓️ Study Start (Actual) 29 July 2021
🗓️ Primary Completion (Estimated) 30 May 2025
✅ Study Completion (Estimated) 30 May 2026
👥 Enrollment (Estimated) 245
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

  • Inclusion criteria (Aim 1):
  • * Men and women between the ages of 45 and 80 years undergoing non-cardiac general or vascular surgery
  • * BMI ≥30 kg/m\^2 without a previously known history of DM
  • Inclusion criteria (Aim 2):
  • * Men and women without known history of diabetes with ages between 45 and 80 years undergoing non-cardiac general or vascular surgery participating in Aim 1.
  • * BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c.
  • Exclusion criteria (Aim 1):
  • * 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
  • Exclusion criteria (Aim 2):

Exclusion Criteria:

  • * 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)
Ages Eligible for Study: 45 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 April 2021
  • First Submitted that Met QC Criteria 23 April 2021
  • First Posted 27 April 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 April 2023
  • Last Update Posted 1 May 2023
  • Last Verified April 2023