Trial Outcomes & Findings for Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients (NCT NCT04862234)

NCT ID: NCT04862234

Last Updated: 2025-01-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

During hospitalization (up to 5 days postoperatively)

Results posted on

2025-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	Dulaglutide Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.	Placebo Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.
Overall Study STARTED	8	8
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Dulaglutide Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.	Placebo Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.
Overall Study Surgery cancellation	1	2
Overall Study Early discharge (<48 hours) - no CGM data collected	0	1
Overall Study Early discharge (<48 hours) - CGM data collected	0	1

Baseline Characteristics

Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dulaglutide n=8 Participants Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.	Placebo n=8 Participants Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

Population: This analysis includes participants with CGM data. One participant who completed the study in the dulaglutide group did not have CGM data available. One participant in the placebo group, who did not complete the study due to being discharged with less than a 48 hour stay, did have CGM data collected and those data are included in this analysis.

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.

Outcome measures

Outcome measures
Measure	Dulaglutide n=6 Participants Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.	Placebo n=5 Participants Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.
Percentage of Time in Target Glucose Range (70-140 mg/dL) by CGM	84.19 percentage of time Standard Deviation 19.70	71.82 percentage of time Standard Deviation 27.26

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The percentage of time in hyperglycemia with glucose\>140 mg/dL will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The percentage of time in hyperglycemia with glucose\>180 mg/dL will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The percentage of time in hypoglycemia with glucose \<70 mg/dL will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The percentage of time in hypoglycemia with glucose \<54 mg/dL will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The percentage of time in hypoglycemia with glucose \<40 mg/dL will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The mean onset time of stress hyperglycemia during the postoperative period by CGM data will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The mean duration of stress hyperglycemia during the postoperative period by CGM data will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The mean daily glucose values, as measured by both point of care (POC) glucose testing and CGM data, will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

The maximum daily glucose values, as measured by both POC glucose testing and CGM data, will be examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During hospitalization (up to 5 days postoperatively)

Perioperative insulin requirements will be assessed as the total daily insulin dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 48 to 72 hours postoperatively

Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 48 to 72 hours postoperatively

Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 48 to 72 hours postoperatively

Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 48 to 72 hours postoperatively

Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 48 to 72 hours postoperatively

Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 48 to 72 hours postoperatively

Samples will be collected prior to surgery and 48 to 72 hours after surgery to assess inflammatory and oxidative stress biomarkers.

Outcome measures

Outcome data not reported

Adverse Events

Dulaglutide

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dulaglutide n=8 participants at risk Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.	Placebo n=8 participants at risk Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.
Cardiac disorders Prolonged hospital length of stay due to tachycardia	12.5% 1/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.	0.00% 0/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.

Other adverse events

Other adverse events
Measure	Dulaglutide n=8 participants at risk Participants randomized to receive dulaglutide within 72 hours prior to a planned surgery.	Placebo n=8 participants at risk Participants randomized to receive a placebo to match dulaglutide within 72 hours prior to a planned surgery.
Gastrointestinal disorders Nausea, vomiting, constipation	12.5% 1/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.	0.00% 0/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.
Endocrine disorders Hypoglycemia, prior to study medication administration	12.5% 1/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.	0.00% 0/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.
Cardiac disorders Tachycardia	12.5% 1/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.	12.5% 1/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.	12.5% 1/8 • Information on adverse events was collected from the time that individuals gave consent to participate in the study through the final assessment at hospital discharge, up to 5 days postoperatively.

Additional Information

Georgia Davis, MD

Emory University

Phone: 404-251-8957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place