Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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. This proposal seeks to identify underlying risk factors in the development of stress hyperglycemia, and will investigate the use of a long-acting glucagon-like peptide-1 receptor agonist for the prevention of stress hyperglycemia in a high-risk surgical population.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dulaglutide Dulaglutide is a fusion protein of a GLP-1 analogue and a modified IgG Fc fragment, leading to a longer acting, relatively flat insulinotropic profile with increased plasma half-life suitable for once-weekly administration. |
Drug: Dulaglutide
Dulaglutide will be administered within 72 hours prior to planned surgical intervention.
Device: Continuous glucose monitor (CGM), blinded
Continuous glucose monitor (CGM) sensor will be placed preoperatively and continued during surgical hospitalization to monitor glucose levels. CGM provides an estimated capillary BG level through direct measurement of interstitial glucose levels every 5-15 minutes.
|
| Placebo Comparator: Placebo Saline placebo. |
Drug: Placebo
Saline Placebo will be administered within 72 hours prior to planned surgical intervention.
Device: Continuous glucose monitor (CGM), blinded
Continuous glucose monitor (CGM) sensor will be placed preoperatively and continued during surgical hospitalization to monitor glucose levels. CGM provides an estimated capillary BG level through direct measurement of interstitial glucose levels every 5-15 minutes.
|
Outcome Measures
Primary Outcome Measures
- Incidence of stress hyperglycemia (SH) [Up to 14 days (depending on length of hospitalization)]
Incidence of SH will be recorded.
- Percentage of time with glucose >140 mg/dL [Up to 14 days (depending on length of hospitalization)]
Percentage of time with glucose >140 mg/dL, as determined by CGM data will be calculated.
- Incidence of any perioperative complications [Up to 14 days (depending on length of hospitalization)]
Occurrence of any perioperative complications will be recorded.
- Percentage of time in target glucose range (70-140 mg/dL) by CGM [Up to 14 days (depending on length of hospitalization)]
Proportion of time in target glucose range (70-140 mg/dL) by CGM data will be calculated
Secondary Outcome Measures
- Baseline insulin secretion between patients with and without stress hyperglycemia (SH) [Baseline]
Baseline insulin secretion between patients with and without SH will be calculated
- Baseline insulin sensitivity between patients with and without stress hyperglycemia (SH) [Baseline]
Baseline insulin sensitivity between patients with and without SH will be calculated
- Maximum daily glucose values measured by POC (point of care testing) [Up to 14 days (depending on length of hospitalization)]
Maximum daily glucose values measured by POC will be recorded
- Maximum daily glucose values measured by CGM (continues glucose monitoring) [Up to 14 days (depending on length of hospitalization)]
Maximum daily glucose values measured by CGM data will be recorded
- Total daily insulin dose in patients with and without stress hyperglycemia (SH) [Up to 14 days (depending on length of hospitalization)]
Total daily insulin dose in patients with and without stress hyperglycemia (SH) will be calculated.
- Length of hospital stay in patients with and without stress hyperglycemia (SH) [Up to 14 days (depending on length of hospitalization)]
Length of hospital stay in patients with and without stress hyperglycemia (SH) will be recorded
- Number of ICU transfers in patients with and without stress hyperglycemia (SH) [Up to 14 days (depending on length of hospitalization)]
Number of ICU transfers in patients with and without stress hyperglycemia (SH) will be recorded
- Number of hospital readmissions after discharge in patients with and without stress hyperglycemia (SH) [Up to 3 months after discharge]
Number of hospital readmissions after discharge patients with and without stress hyperglycemia (SH) will be recorded
- Number of emergency room visits after discharge in patients with and without stress hyperglycemia (SH) [Up to 3 months after discharge]
Number of emergency room visits after discharge patients with and without stress hyperglycemia (SH) will be recorded
- Total number of following complications: wound infection, respiratory failure, pneumonia, acute kidney injury (increase in creatinine by 0.5 mg/dL), and major adverse cardiac events (MACE). [Up to 14 days (depending on length of hospitalization)]
Total number of following complications: wound infection, respiratory failure, pneumonia, acute kidney injury (increase in creatinine by 0.5 mg/dL), and major adverse cardiac events (MACE) will be calculated.
- Percentage of time in hyperglycemia (>140 mg/dL) [Up to 14 days (depending on length of hospitalization)]
Time-in-hyperglycemia (>140 mg/dL) will be recorded.
- Percentage of time in hyperglycemia (>180 mg/dL) [Up to 14 days (depending on length of hospitalization)]
Time-in-hyperglycemia (>180 mg/dL) will be recorded.
- Percentage of time in hypoglycemia (glucose <70 mg/dL) [Up to 14 days (depending on length of hospitalization)]
Percentage of time in hypoglycemia (glucose <70 mg/dL) will be recorded.
- Percentage of time in hypoglycemia (glucose <54 mg/dL) [Up to 14 days (depending on length of hospitalization)]
Percentage of time in hypoglycemia (glucose <54 mg/dL) will be recorded.
- Percentage of time in hypoglycemia (glucose <40 mg/dL) [Up to 14 days (depending on length of hospitalization)]
Percentage of time in hypoglycemia (glucose <40 mg/dL) will be recorded.
- Mean onset time of stress hyperglycemia (SH) during the postoperative period by CGM data. [Up to 14 days (depending on length of hospitalization)]
Mean onset time of stress hyperglycemia (SH) will be recorded.
- Mean duration of stress hyperglycemia (SH)during the postoperative period by CGM data [Up to 14 days (depending on length of hospitalization)]
Mean duration of stress hyperglycemia (SH) will be recorded.
- Mean daily glucose values measured by POC (point of care) [Up to 14 days (depending on length of hospitalization)]
Mean daily glucose values measured by POC (point of care) will be calculated.
- Mean daily glucose values measured by CGM (continues glucose monitoring) [Up to 14 days (depending on length of hospitalization)]
Mean daily glucose values measured by CGM (continues glucose monitoring) will be calculated.
- Perioperative insulin requirements (total daily insulin dose). [Up to 14 days (depending on length of hospitalization)]
Perioperative insulin requirements (total daily insulin dose) will be recorded.
- Baseline and Postoperative inflammatory biomarker level [Up to 14 days (depending on length of hospitalization)]
Baseline and Postoperative inflammatory biomarker level will be measured.
- Baseline and Postoperative oxidative stress biomarker level [Up to 14 days (depending on length of hospitalization)]
Baseline and Postoperative oxidative stress biomarker level will be measured.
Eligibility Criteria
Criteria
Inclusion criteria
Inclusion criteria (Aim 1):
-
Men and women between the ages of 45 and 80 years undergoing non-cardiac general or vascular surgery
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BMI ≥30 kg/m2 without a previously known history of DM
Inclusion criteria (Aim 2):
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Men and women without known history of diabetes with ages between 45 and 80 years undergoing non-cardiac general or vascular surgery participating in Aim 1.
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BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c.
Exclusion Criteria:
Exclusion criteria (Aim 1):
-
Patients prescribed or taking antihyperglycemic medications
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Patients undergoing cardiac surgery or patients anticipated to require ICU care
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Patients expected to be admitted less than 48-72 hours after surgery
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Severely impaired renal function (eGFR < 30 mL/min) or clinically significant hepatic failure
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Treatment with oral (equivalent to prednisone > 5 mg/day) or injectable corticosteroids
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Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; unable to consent
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Pregnant or breast feeding at time of enrollment
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Prisoners
Exclusion criteria (Aim 2):
-
Same as in Aim 1, with the following additional exclusion criteria:
-
Patients undergoing gastrointestinal surgery or at high risk for gastrointestinal obstruction/ileus or expected to require gastrointestinal suction
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Patients with delayed gastric emptying, pancreatic or gallbladder disease
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Patients with personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
| 2 | Grady Hospital | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Georgia Davis, MD, Emory University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00097659
- K23DK122199