Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

Conditions

• Stress Hyperglycemia

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Dulaglutide Injection — DRUG
  Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Dulaglutide injection: 0.75 mg/0.5 mL solution in a single-dose pen 1 to 3 days prior to surgery
• Saline Injection — OTHER
  Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Saline injection/0.5 mL pre-drawn solution 1 to 3 days prior to surgery

Study Details

This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.

Key Dates

Start date

Mar 8, 2019

Status verified

May 2024

Primary completion

May 2, 2023

Completion

May 2, 2023

Study Design

Enrollment

28 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dulaglutide Arm
  Participants without a history of DM who are randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery.
• Placebo Comparator: Placebo Arm
  Participants without a history of DM who are randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery.

Primary Outcome Measure

Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period [ Time Frame: During the hospital stay (up to 12 days postoperatively) ]

Locations (3)

Find similar trials in Atlanta, GA

Related Studies

• Perioperative Glucose Monitoring and Treatment to Reduce Risk of Surgical Site Infections and Complications
  Enrolling By Invitation · St. Peter's Hospital, Albany, NY · Albany, New York