Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Hyperglycemia Stress
In brief
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.
Key facts
- Study ID
- NCT04862234
- Run by
- Emory University
- People needed
- 16
- Starts
- 2021-08-06
- Expected to finish
- 2023-06-22
- Last updated by the study team
- 2025-01-17
Who can join
Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Emory University Hospital — Atlanta, Georgia, United States
- Grady Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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