Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

NCT04862234 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB00097659K23DK122199
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hyperglycemia Stress

Keywords

Perioperative; Surgery; Stress Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM

  The percentage of time in the target glucose range of 70-140 mg/dL, as measured by a continuous glucose monitor (CGM) data was determined.

  During hospitalization (up to 5 days postoperatively)

Secondary Outcomes (16)

• Percentage of Time in Hyperglycemia (Glucose>140 mg/dL)

  During hospitalization (up to 5 days postoperatively)

• Percentage of Time in Hyperglycemia (Glucose>180 mg/dL)

  During hospitalization (up to 5 days postoperatively)

• Percentage of Time in Hypoglycemia (Glucose <70 mg/dL)

  During hospitalization (up to 5 days postoperatively)

• Percentage of Time in Hypoglycemia (Glucose <54 mg/dL)

  During hospitalization (up to 5 days postoperatively)

• Percentage of Time in Hypoglycemia (Glucose <40 mg/dL)

  During hospitalization (up to 5 days postoperatively)

Study Arms (2)

Dulaglutide

EXPERIMENTAL

Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.

Drug: Dulaglutide; Device: Continuous glucose monitor (CGM), blinded

Placebo

PLACEBO COMPARATOR

Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.

Drug: Placebo; Device: Continuous glucose monitor (CGM), blinded

Interventions

Dulaglutide DRUG

A subcutaneous injection of dulaglutide 0.75 mg will be administered within 72 hours prior to a planned surgical intervention.

Also known as: Trulicity

Dulaglutide

Placebo DRUG

A subcutaneous injection of a saline placebo will be administered within 72 hours prior to a planned surgical intervention.

Placebo

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.

Also known as: FreeStyle Libre Pro

Dulaglutide; Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Grady Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

dulaglutide; Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Limitations and Caveats

This clinical trial was performed concurrently with an observational study which will continue until May 2025. Laboratory analysis of samples will be performed after completion of data collection for the observational study.

Results Point of Contact

• Title: Georgia Davis, MD
• Organization: Emory University

georgia.marie.davis@emory.edu

404-251-8957

Study Officials

• Georgia Davis, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: August 6, 2021
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available for sharing beginning 3 months and ending 5 years following article publication.
• Access Criteria: Data will be made available for sharing with researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal. Proposals should be directed to gmdavis@emory.edu. To gain access, data requestors will need to sign a data access/use agreement.

Locations

US (2)