Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04862234
Phase
PHASE4
Status
Terminated

Conditions

  • Hyperglycemia Stress

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide — DRUG
    A subcutaneous injection of dulaglutide 0.75 mg will be administered within 72 hours prior to a planned surgical intervention.
  • Placebo — DRUG
    A subcutaneous injection of a saline placebo will be administered within 72 hours prior to a planned surgical intervention.
  • Continuous glucose monitor (CGM), blinded — DEVICE
    Continuous glucose monitor (CGM) sensor will be placed preoperatively and continued during surgical hospitalization to monitor glucose levels. CGM provides an estimated capillary blood glucose (BG) level through direct measurement of interstitial glucose levels every 5-15 minutes.

Study Details

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 Dates

Start date
Aug 6, 2021
Status verified
Dec 2024
Primary completion
Jun 22, 2023
Completion
Jun 22, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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 Outcome Measure

Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM [ Time Frame: During hospitalization (up to 5 days postoperatively) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-
Grady HospitalAtlantaGeorgia30322-

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