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This is a medical research study designed to see if an infusion of a naturally occurring hormone, GLP-1, works when used to decrease blood sugar during cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | This active arm is a continuous infusion of GLP-1 during cardiac surgery |
|
| 2 | Placebo Comparator | This is a continuous infusion of normal saline solution infusion as placebo at (1.5 pmol/kg/min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP 1 | Biological | This a continuous intravenous infusion of GLP-1 (7-36) amide infusion (1.5 pmol/kg/min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels. | During surgery and 24 hours after |
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Inclusion Criteria:
Exclusion Criteria:
concomitant surgery (e.g. carotid endarterectomy),
emergent surgery,
current steroid use,
insulin dependent diabetes mellitus (IDDM),
cardiac surgery without the use of cardiopulmonary bypass (e.g. off-pump CABG),
current use of positive intravenous inotropic agents,
serious intercurrent illness (endocarditis, sepsis, active malignancy requiring treatment) or active infection,
known substance abuse,
receipt of an investigational drug or device within 30 days prior to surgery,
known allergy to any of the following: GLP-1, fentanyl, midazolam, isoflurane, propofol, morphine, heparin or protamine,
Sulfonylurea medication administration on morning of surgery (such as, tolbutamide, tolazamide (Tolinase), chlorpropamide (Diabinese). glipizide (Glucotrol, Glucotrol XL), glyburide (Micronase, Glynase PresTabs, and DiaBeta), glimepiride (Amaryl),
Major end organ dysfunction defined as:
Patients with a history of or risk factors for acute pancreatitis (i.e. ethanol abuse, gall stones) will be excluded from this study,
Pregnant or breastfeeding females, or
any other condition that, in the opinion of the investigator, may compromise the safety of the subject or would preclude the subject from successful completion of the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 16, 2015 | |
| Reset | Oct 14, 2015 | |
| Release | Mar 28, 2016 | |
| Reset | Apr 28, 2016 | |
| Release | Aug 3, 2017 | |
| Reset | Sep 5, 2017 | |
| Release | Sep 6, 2017 | |
| Reset | Oct 3, 2017 | |
| Release | Oct 3, 2017 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 16, 2015 | Oct 14, 2015 | |||
| Mar 28, 2016 |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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| normal saline solution placebo | Biological | This is a continuous intravenous infusion of normal saline solution as placebo (1.5 pmol/kg/min) during cardiac surgery |
|
| Apr 28, 2016 |
| Aug 3, 2017 | Sep 5, 2017 |
| Sep 6, 2017 | Oct 3, 2017 |
| Oct 3, 2017 | Yes |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |