Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Dulaglutide

Criteria

Inclusion criteria

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/m2 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:

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):

• Same as in Aim 1, with the following additional 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)