FFA Hypertension and Inflammation in Lean and Obese Subjects

Free Fatty Acids-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00721617

Acronym

FFAADA

Enrollment

Registered

2008-07-24

Start date

2009-04-30

Completion date

2011-06-30

Last updated

2015-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension, Obesity

Brief summary

Although a large number of obese patients develop high blood pressure, the cause is unknown. The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the development of high blood pressure in obese people.

Detailed description

Recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs) increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory markers in subjects with and without diabetes. The effects of FFA on blood pressure and vasculature have not been fully investigated. A group of 12 obese nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 4 occasions. Research subjects will receive, in random order, a 8-hour intravenous (IV) infusion of Intralipid 20% at 40 mL/h (a fat solution), 8-hour IV infusion of normal saline at 40 mL/h, 8-hour IV infusion of dextrose (sugar) 10% at 40 mL/h, and a 8-hour intravenous (IV) infusion combination of Intralipid 20% and dextrose 10% at 40mL/h.

Interventions

OTHERIntralipid 20%

Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours.

OTHERNormal Saline

Lean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours.

OTHEROral fat load

Lean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Males or females * Obese subjects (body mass index (BMI) ≥ 30 kg/m\^2) * 18 and 65 years * Blood pressure reading \< 140/80 mm Hg and no prior history of hypertension

Exclusion criteria

* History of diabetes mellitus * History of hypertension * Fasting triglyceride levels \> 250 mg/dL * Liver disease (ALT 2.5x \> upper limit of normal) * Serum creatinine ≥1.5 mg/dL * Smokers, drug or alcohol abuse * Mental condition rendering the subject unable to understand the scope and possible consequences of the study * Female subjects who are pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame	Description
Change in Flow-mediated Dilation From Baseline to 4 Hours	Baseline, 4 hours	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. FMD is expressed as the change in diameter from baseline to 4 hours.
Change in Systolic Blood Pressure From Baseline to 4 Hours	Baseline, 4 hours	Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.
Change in Systolic Blood Pressure From Baseline to 8 Hours	Baseline, 8 hours	Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.
Change in Diastolic Blood Pressure From Baseline to 4 Hours	Baseline, 4 hours	Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.
Change in Diastolic Blood Pressure From Baseline to 8 Hours	Baseline, 8 hours	Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.

Secondary

Measure	Time frame	Description
Plasma Glucose Levels for Intralipid Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.
Plasma Glucose Levels for Dextrose Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.
Plasma Glucose Levels for Intralipid/Dextrose Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.
Insulin Levels for Saline Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
Insulin Levels for Intralipid Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours	Baseline, 4 hours	Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.
Insulin Levels for Intralipid/Dextrose Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
C-peptides Levels for Saline Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL. A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
C-peptides Levels for Intralipid Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after Intralipid infusion, and 8 hours after Intralipid infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL. A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
C-peptides Levels for Dextrose Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL. A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
C-peptides Levels for Intralipid/Dextrose Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL. A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
Insulin Levels for Dextrose Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours	Baseline, 8 hours	Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.
Change in Triglyceride Levels From Baseline to 4 Hours	Baseline, 4 hours	Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.
Change in Triglyceride Levels From Baseline to 8 Hours	Baseline, 8 hours	Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.
Plasma Glucose Levels for Saline Infusion	Baseline, 4 hours, 8 hours	Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from Grady Memorial Hospital

Pre-assignment details

All subjects had a 2-hour glucose of less than 200 mg/dL during a 75 g oral glucose tolerance test and a fasting glucose of less than 126 mg/dL.

Participants by arm

Arm	Count
Healthy Subjects Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h.	12
Total	12

Baseline characteristics

Characteristic	Healthy Subjects
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

Change in Diastolic Blood Pressure From Baseline to 4 Hours

Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.

Time frame: Baseline, 4 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 4 Hours	Saline	-1.25 mmHg	Standard Deviation 2.7
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 4 Hours	Dextrose 10%	-2.08 mmHg	Standard Deviation 9.26
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 4 Hours	Intralipid 20%	6.2 mmHg	Standard Deviation 2.35
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 4 Hours	Intralipid/Dextrose	-4.27 mmHg	Standard Deviation 14.95

Primary

Change in Diastolic Blood Pressure From Baseline to 8 Hours

Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.

Time frame: Baseline, 8 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 8 Hours	Saline	1.2 mmHg	Standard Deviation 10.5
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 8 Hours	Intralipid 20%	4.8 mmHg	Standard Deviation 6.2
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 8 Hours	Dextrose 10%	-0.83 mmHg	Standard Deviation 9.7
Healthy Subjects	Change in Diastolic Blood Pressure From Baseline to 8 Hours	Intralipid/Dextrose	2.7 mmHg	Standard Deviation 9

Primary

Change in Flow-mediated Dilation From Baseline to 4 Hours

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. FMD is expressed as the change in diameter from baseline to 4 hours.

Time frame: Baseline, 4 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in Flow-mediated Dilation From Baseline to 4 Hours	Saline	0.16 percent change in diameter	Standard Deviation 4.9
Healthy Subjects	Change in Flow-mediated Dilation From Baseline to 4 Hours	Intralipid 20%	-3.2 percent change in diameter	Standard Deviation 1.4
Healthy Subjects	Change in Flow-mediated Dilation From Baseline to 4 Hours	Dextrose 10%	-0.9 percent change in diameter	Standard Deviation 1.8
Healthy Subjects	Change in Flow-mediated Dilation From Baseline to 4 Hours	Intralipid/Dextrose	-2.4 percent change in diameter	Standard Deviation 2.1

Primary

Change in Systolic Blood Pressure From Baseline to 4 Hours

Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.

Time frame: Baseline, 4 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 4 Hours	Intralipid/Dextrose	1.91 mmHg	Standard Error 5
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 4 Hours	Saline	1.92 mmHg	Standard Error 4.01
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 4 Hours	Intralipid 20%	12.58 mmHg	Standard Error 2.1
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 4 Hours	Dextrose 10%	3.00 mmHg	Standard Error 3.35

Primary

Change in Systolic Blood Pressure From Baseline to 8 Hours

Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.

Time frame: Baseline, 8 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 8 Hours	Saline	0.33 mmHg	Standard Error 4.89
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 8 Hours	Dextrose 10%	2.58 mmHg	Standard Error 3.09
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 8 Hours	Intralipid 20%	12.08 mmHg	Standard Error 2.48
Healthy Subjects	Change in Systolic Blood Pressure From Baseline to 8 Hours	Intralipid/Dextrose	12.9 mmHg	Standard Error 6.62

Secondary

Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours

Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.

Time frame: Baseline, 4 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours	Saline	-0.05 mmol/L	Standard Deviation 0.27
Healthy Subjects	Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours	Intralipid 20%	0.84 mmol/L	Standard Deviation 0.8
Healthy Subjects	Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours	Dextrose 10%	-0.13 mmol/L	Standard Deviation 0.43
Healthy Subjects	Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours	Intralipid/Dextrose	-0.11 mmol/L	Standard Deviation 0.48

Secondary

Change in Triglyceride Levels From Baseline to 4 Hours

Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.

Time frame: Baseline, 4 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in Triglyceride Levels From Baseline to 4 Hours	Intralipid 20%	118.9 mg/dL	Standard Error 86.7
Healthy Subjects	Change in Triglyceride Levels From Baseline to 4 Hours	Saline	-0.83 mg/dL	Standard Error 37.7
Healthy Subjects	Change in Triglyceride Levels From Baseline to 4 Hours	Dextrose 10%	-4.99 mg/dL	Standard Error 51.2
Healthy Subjects	Change in Triglyceride Levels From Baseline to 4 Hours	Intralipid/Dextrose	39.6 mg/dL	Standard Error 30.56

Secondary

Change in Triglyceride Levels From Baseline to 8 Hours

Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.

Time frame: Baseline, 8 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Change in Triglyceride Levels From Baseline to 8 Hours	Intralipid 20%	121.1 mg/dL	Standard Deviation 96.8
Healthy Subjects	Change in Triglyceride Levels From Baseline to 8 Hours	Dextrose 10%	3.98 mg/dL	Standard Deviation 62.3
Healthy Subjects	Change in Triglyceride Levels From Baseline to 8 Hours	Intralipid/Dextrose	47.3 mg/dL	Standard Deviation 50.7
Healthy Subjects	Change in Triglyceride Levels From Baseline to 8 Hours	Saline	2.1 mg/dL	Standard Deviation 38.3

Secondary

Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours

Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.

Time frame: Baseline, 8 hours

Arm	Measure	Group	Value (MEAN)	Dispersion
Healthy Subjects	Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours	Saline	0.03 mmol/L	Standard Deviation 0.46
Healthy Subjects	Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours	Intralipid 20%	1.03 mmol/L	Standard Deviation 1.1
Healthy Subjects	Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours	Dextrose 10%	-0.18 mmol/L	Standard Deviation 0.46
Healthy Subjects	Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours	Intralipid/Dextrose	-0.1 mmol/L	Standard Deviation 0.3

Secondary

C-peptides Levels for Dextrose Infusion

Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL. A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.