Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

NCT03743025 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB000979631K23GM128221-01A1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stress Hyperglycemia

Keywords

Coronary Artery Bypass Surgery (CABG); Post Operative; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

  Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels \>140 milligrams per deciliter (mg/dL). Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

  During the hospital stay (up to 12 days postoperatively)

Secondary Outcomes (18)

• Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively

  During the ICU stay (up to 7 days postoperatively)

• Number of Participants Needing CII Treatment in the ICU

  During the ICU stay (up to 7 days postoperatively)

• Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII

  During the hospital stay (up to 12 days postoperatively)

• Mean Blood Glucose Levels During the Hospital Stay

  During the hospital stay (up to 12 days postoperatively)

• Mean Units Per Hour of Insulin While in the ICU

  During the ICU stay (up to 7 days postoperatively)

Study Arms (2)

Dulaglutide Arm

EXPERIMENTAL

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.

Drug: Dulaglutide Injection

Placebo Arm

PLACEBO COMPARATOR

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.

Other: Saline Injection

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

Also known as: Trulicity

Dulaglutide Arm

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

Also known as: Sodium Chloride Injection

Placebo Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the ages of 40 and 80 years
• Body mass index (BMI) ≥25
• Undergoing elective CABG surgery
• No previous history of diabetes or hyperglycemia

You may not qualify if:

• Hyperglycemia (BG\>125 mg/dl or HbA1c \> 6.5%) or previous treatment with antidiabetic agents
• Impaired renal function (GFR \< 30 ml/min) or clinically significant hepatic failure
• Gastrointestinal obstruction expected to require gastrointestinal suction
• Patients with clinically relevant pancreatic or gallbladder disease
• Treatment with oral or injectable corticosteroid
• Mental condition rendering the subject unable to understand the possible consequences of the study
• Pregnancy or breastfeeding at time of enrollment

Sponsors & Collaborators

• Emory University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (3)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

dulaglutide; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Francisco J. Pasquel
• Organization: Emory University

fpasque@emory.edu

404-778-1695

Study Officials

• Francisco Pasquel, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective placebo controlled randomized study

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 15, 2018
• Study Start: March 8, 2019
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)