Diseases, Metabolic, Insulin Sensitivity
Conditions
Keywords
Intravenous Feeding, Lipid Emulsions, Intravenous
Brief summary
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.
Interventions
DRUGIntralipid
Infusion of Intralipid (soybean-derived fat)
DRUGClinOleic
Infusion of ClinOleic (olive oil-based)
DRUGDextrose
Infusion of dextrose (sugar) without fat
OTHERSaline (control)
Infusion of 0.9% normal saline
Sponsors
Baxter Healthcare Corporation
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years
Exclusion criteria
* The patient is pregnant or breast feeding * Subjects have or with history of diabetes, hypertension, fasting triglyceride levels \> 250 mg/dL, liver disease (ALT 2.5x \> upper limit of normal), serum creatinine ≥1.5 mg/dL * Smokers or ex-smoker \< 3 months of cessation, drug or alcohol abuse * Mental condition rendering the subject unable to understand the scope and possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation | Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
An overnight fast, subjects underwent research studies in the morning with the infusion starting between 1200 and 1300 h.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Healthy Volunteer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Flow Mediated Dilation | 10.3 percentage of brachial artery diameter | Standard Error 0.88 |
| ClinOleic | Flow Mediated Dilation | 8.9 percentage of brachial artery diameter | Standard Error 0.8 |
| Dextrose | Flow Mediated Dilation | 9.2 percentage of brachial artery diameter | Standard Error 0.72 |
| Saline | Flow Mediated Dilation | 9.1 percentage of brachial artery diameter | Standard Error 0.58 |
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.
Time frame: 4 hours after infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Flow Mediated Dilation | 7.9 percentage of brachial artery diameter | Standard Error 0.83 |
| ClinOleic | Flow Mediated Dilation | 9.0 percentage of brachial artery diameter | Standard Error 0.88 |
| Dextrose | Flow Mediated Dilation | 8.3 percentage of brachial artery diameter | Standard Error 0.67 |
| Saline | Flow Mediated Dilation | 8.2 percentage of brachial artery diameter | Standard Error 1.37 |
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.
Time frame: 24 hours after infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Flow Mediated Dilation | 7.2 percentage of brachial artery diameter | Standard Error 0.74 |
| ClinOleic | Flow Mediated Dilation | 9.1 percentage of brachial artery diameter | Standard Error 0.91 |
| Dextrose | Flow Mediated Dilation | 10.2 percentage of brachial artery diameter | Standard Error 1.15 |
| Saline | Flow Mediated Dilation | 9.7 percentage of brachial artery diameter | Standard Error 0.89 |