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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Many patients in the hospital who are malnourished or not eating received intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions. The investigators believe that the high sugar and high fat content can limit the ability to fight infections and produce stiffness of blood vessels. This study will compare the effect of high sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel function. The investigators will also compare the effect of different fats (olive oil and soybean) in the TPN solution on the risk of infection and blood vessel function on a total of 12 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer | Active Comparator | Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralipid | Drug | Infusion of Intralipid (soybean-derived fat) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilation | Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100. | Baseline |
| Flow Mediated Dilation | Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 4 hour diameter)/4 hour diameter × 100. | 4 hours after infusion |
| Flow Mediated Dilation | Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 24 hour diameter)/24 hour diameter × 100. | 24 hours after infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21832112 | Result | Siqueira J, Smiley D, Newton C, Le NA, Gosmanov AR, Spiegelman R, Peng L, Osteen SJ, Jones DP, Quyyumi AA, Ziegler TR, Umpierrez GE. Substitution of standard soybean oil with olive oil-based lipid emulsion in parenteral nutrition: comparison of vascular, metabolic, and inflammatory effects. J Clin Endocrinol Metab. 2011 Oct;96(10):3207-16. doi: 10.1210/jc.2011-0480. Epub 2011 Aug 10. |
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An overnight fast, subjects underwent research studies in the morning with the infusion starting between 1200 and 1300 h.
All subjects seen at Grady Memorial Hospital Clinical Interactions Network unit of the Atlanta Clinical and Translational Science Institute. Subjects were admitted on the afternoon before the study protocol began.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteer | Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control) Intralipid ClinOleic Dextrose Saline (control) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 Hour (Baseline) of Saline Infusion |
| |||||||||||||
| 4 Hours Into Saline Infusion |
| |||||||||||||
| 24 Hours Into Saline Infusion |
| |||||||||||||
| 0 Hour (Baseline) of Intralipid Infusion |
| |||||||||||||
| 4 Hours Into Intralipid Infusion |
| |||||||||||||
| 24 Hours Into Intralipid Infusion |
| |||||||||||||
| 0 Hour (Baseline) of ClinOleic Infusion |
| |||||||||||||
| 4 Hours Into ClinOleic Infusion |
| |||||||||||||
| 24 Hours Into ClinOleic Infusion |
| |||||||||||||
| 0 Hour (Baseline) of Dextrose Infusion |
| |||||||||||||
| 4 Hours Into Dextrose Infusion |
| |||||||||||||
| 24 Hours Into Dextrose Infusion |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteer | Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control) Intralipid ClinOleic Dextrose Saline (control) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Flow Mediated Dilation | Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100. | Posted | Mean | Standard Error | percentage of brachial artery diameter | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteer | Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control) |
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Short duration and involved healthy volunteers--not clear whether the use of olive oil-based lipid emulsions may result in improved clinical outcomes over traditional lipid emulsions in hospitalized patients with medical and surgical illness.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez | Emory University | 404-778-1665 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
| C568346 | ClinOleic |
| D005947 | Glucose |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D002712 |
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| ClinOleic |
| Drug |
Infusion of ClinOleic (olive oil-based) |
|
| Dextrose | Drug | Infusion of dextrose (sugar) without fat |
|
| Saline (control) | Other | Infusion of 0.9% normal saline |
|
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Dextrose |
Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat |
| OG003 | Saline | Healthy subjects receive 24-hour infusion of normal saline (control) |
|
|
| Primary | Flow Mediated Dilation | Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 4 hour diameter)/4 hour diameter × 100. | Posted | Mean | Standard Error | percentage of brachial artery diameter | 4 hours after infusion |
|
|
|
| Primary | Flow Mediated Dilation | Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 24 hour diameter)/24 hour diameter × 100. | Posted | Mean | Standard Error | percentage of brachial artery diameter | 24 hours after infusion |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |