Trial Outcomes & Findings for FFA Hypertension and Inflammation in Lean and Obese Subjects (NCT NCT00721617)

NCT ID: NCT00721617

Last Updated: 2015-07-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline, 4 hours
• Results posted on: 2015-07-27

Participant Flow

Subjects were recruited from Grady Memorial Hospital

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.

Participant milestones

Measure	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
0 Hour (Baseline) of Saline Infusion STARTED	12
0 Hour (Baseline) of Saline Infusion COMPLETED	12
0 Hour (Baseline) of Saline Infusion NOT COMPLETED	0
4 Hours Into Saline Infusion STARTED	12
4 Hours Into Saline Infusion COMPLETED	12
4 Hours Into Saline Infusion NOT COMPLETED	0
8 Hours Into Saline Infusion STARTED	12
8 Hours Into Saline Infusion COMPLETED	12
8 Hours Into Saline Infusion NOT COMPLETED	0
0 Hour (Baseline) of Intralipid Infusion STARTED	12
0 Hour (Baseline) of Intralipid Infusion COMPLETED	12
0 Hour (Baseline) of Intralipid Infusion NOT COMPLETED	0
4 Hours Into Intralipid Infusion STARTED	12
4 Hours Into Intralipid Infusion COMPLETED	12
4 Hours Into Intralipid Infusion NOT COMPLETED	0
8 Hours Into Intralipid Infusion STARTED	12
8 Hours Into Intralipid Infusion COMPLETED	12
8 Hours Into Intralipid Infusion NOT COMPLETED	0
0 Hour (Baseline) of Dextrose Infusion STARTED	12
0 Hour (Baseline) of Dextrose Infusion COMPLETED	12
0 Hour (Baseline) of Dextrose Infusion NOT COMPLETED	0
4 Hours Into Dextrose Infusion STARTED	12
4 Hours Into Dextrose Infusion COMPLETED	12
4 Hours Into Dextrose Infusion NOT COMPLETED	0
8 Hours Into Dextrose Infusion STARTED	12
8 Hours Into Dextrose Infusion COMPLETED	12
8 Hours Into Dextrose Infusion NOT COMPLETED	0
0 Hour (Baseline) of Intralipid/Dextrose STARTED	12
0 Hour (Baseline) of Intralipid/Dextrose COMPLETED	12
0 Hour (Baseline) of Intralipid/Dextrose NOT COMPLETED	0
4 Hours Into Intralipid/Dextrose STARTED	12
4 Hours Into Intralipid/Dextrose COMPLETED	12
4 Hours Into Intralipid/Dextrose NOT COMPLETED	0
8 Hours Into Intralipid/Dextrose STARTED	12
8 Hours Into Intralipid/Dextrose COMPLETED	12
8 Hours Into Intralipid/Dextrose NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FFA Hypertension and Inflammation in Lean and Obese Subjects

Baseline characteristics by cohort

Measure	Healthy Subjects n=12 Participants 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.
Age, Continuous	41 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in Flow-mediated Dilation From Baseline to 4 Hours Saline	0.16 percent change in diameter Standard Deviation 4.9
Change in Flow-mediated Dilation From Baseline to 4 Hours Intralipid 20%	-3.2 percent change in diameter Standard Deviation 1.4
Change in Flow-mediated Dilation From Baseline to 4 Hours Dextrose 10%	-0.9 percent change in diameter Standard Deviation 1.8
Change in Flow-mediated Dilation From Baseline to 4 Hours Intralipid/Dextrose	-2.4 percent change in diameter Standard Deviation 2.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in Systolic Blood Pressure From Baseline to 4 Hours Saline	1.92 mmHg Standard Error 4.01
Change in Systolic Blood Pressure From Baseline to 4 Hours Intralipid 20%	12.58 mmHg Standard Error 2.1
Change in Systolic Blood Pressure From Baseline to 4 Hours Dextrose 10%	3.00 mmHg Standard Error 3.35
Change in Systolic Blood Pressure From Baseline to 4 Hours Intralipid/Dextrose	1.91 mmHg Standard Error 5.00

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in Systolic Blood Pressure From Baseline to 8 Hours Saline	0.33 mmHg Standard Error 4.89
Change in Systolic Blood Pressure From Baseline to 8 Hours Intralipid 20%	12.08 mmHg Standard Error 2.48
Change in Systolic Blood Pressure From Baseline to 8 Hours Dextrose 10%	2.58 mmHg Standard Error 3.09
Change in Systolic Blood Pressure From Baseline to 8 Hours Intralipid/Dextrose	12.9 mmHg Standard Error 6.62

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in Diastolic Blood Pressure From Baseline to 4 Hours Saline	-1.25 mmHg Standard Deviation 2.7
Change in Diastolic Blood Pressure From Baseline to 4 Hours Intralipid 20%	6.2 mmHg Standard Deviation 2.35
Change in Diastolic Blood Pressure From Baseline to 4 Hours Dextrose 10%	-2.08 mmHg Standard Deviation 9.26
Change in Diastolic Blood Pressure From Baseline to 4 Hours Intralipid/Dextrose	-4.27 mmHg Standard Deviation 14.95

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in Diastolic Blood Pressure From Baseline to 8 Hours Saline	1.2 mmHg Standard Deviation 10.5
Change in Diastolic Blood Pressure From Baseline to 8 Hours Intralipid 20%	4.8 mmHg Standard Deviation 6.2
Change in Diastolic Blood Pressure From Baseline to 8 Hours Dextrose 10%	-0.83 mmHg Standard Deviation 9.7
Change in Diastolic Blood Pressure From Baseline to 8 Hours Intralipid/Dextrose	2.7 mmHg Standard Deviation 9.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours Saline	-0.05 mmol/L Standard Deviation 0.27
Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours Intralipid 20%	0.84 mmol/L Standard Deviation 0.8
Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours Dextrose 10%	-0.13 mmol/L Standard Deviation 0.43
Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours Intralipid/Dextrose	-0.11 mmol/L Standard Deviation 0.48

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours Saline	0.03 mmol/L Standard Deviation 0.46
Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours Intralipid 20%	1.03 mmol/L Standard Deviation 1.1
Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours Dextrose 10%	-0.18 mmol/L Standard Deviation 0.46
Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours Intralipid/Dextrose	-0.1 mmol/L Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in Triglyceride Levels From Baseline to 4 Hours Saline	-0.83 mg/dL Standard Error 37.7
Change in Triglyceride Levels From Baseline to 4 Hours Intralipid 20%	118.9 mg/dL Standard Error 86.7
Change in Triglyceride Levels From Baseline to 4 Hours Dextrose 10%	-4.99 mg/dL Standard Error 51.2
Change in Triglyceride Levels From Baseline to 4 Hours Intralipid/Dextrose	39.6 mg/dL Standard Error 30.56

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Change in Triglyceride Levels From Baseline to 8 Hours Saline	2.1 mg/dL Standard Deviation 38.3
Change in Triglyceride Levels From Baseline to 8 Hours Intralipid 20%	121.1 mg/dL Standard Deviation 96.8
Change in Triglyceride Levels From Baseline to 8 Hours Dextrose 10%	3.98 mg/dL Standard Deviation 62.3
Change in Triglyceride Levels From Baseline to 8 Hours Intralipid/Dextrose	47.3 mg/dL Standard Deviation 50.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Plasma Glucose Levels for Saline Infusion Baseline	86.0 mg/dL Standard Deviation 9.6
Plasma Glucose Levels for Saline Infusion 4 hours	87.0 mg/dL Standard Deviation 20.7
Plasma Glucose Levels for Saline Infusion 8 hours	88.0 mg/dL Standard Deviation 15.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Plasma Glucose Levels for Intralipid Infusion Baseline	78.4 mg/dL Standard Deviation 8.0
Plasma Glucose Levels for Intralipid Infusion 4 hours	75.6 mg/dL Standard Deviation 9.4
Plasma Glucose Levels for Intralipid Infusion 8 hours	73.7 mg/dL Standard Deviation 10.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Plasma Glucose Levels for Dextrose Infusion Baseline	77.4 mg/dL Standard Deviation 12.4
Plasma Glucose Levels for Dextrose Infusion 4 hours	100.4 mg/dL Standard Deviation 19.5
Plasma Glucose Levels for Dextrose Infusion 8 hours	93.0 mg/dL Standard Deviation 13.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Plasma Glucose Levels for Intralipid/Dextrose Infusion Baseline	71.6 mg/dL Standard Deviation 12.3
Plasma Glucose Levels for Intralipid/Dextrose Infusion 4 hours	101.2 mg/dL Standard Deviation 16.6
Plasma Glucose Levels for Intralipid/Dextrose Infusion 8 hours	97.8 mg/dL Standard Deviation 11.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Insulin Levels for Saline Infusion Baseline	8.4 μU/mL Standard Deviation 4.9
Insulin Levels for Saline Infusion 4 hours	11.3 μU/mL Standard Deviation 6.4
Insulin Levels for Saline Infusion 8 hours	10.1 μU/mL Standard Deviation 6.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Insulin Levels for Intralipid Infusion Baseline	9.1 μU/mL Standard Deviation 5.5
Insulin Levels for Intralipid Infusion 4 hours	11.3 μU/mL Standard Deviation 7.7
Insulin Levels for Intralipid Infusion 8 hours	9.3 μU/mL Standard Deviation 7.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Insulin Levels for Dextrose Infusion Baseline	8.4 μU/mL Standard Deviation 9.6
Insulin Levels for Dextrose Infusion 4 hours	25.1 μU/mL Standard Deviation 10.2
Insulin Levels for Dextrose Infusion 8 hours	33.4 μU/mL Standard Deviation 21.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
Insulin Levels for Intralipid/Dextrose Infusion 4 hours	28.0 μU/mL Standard Deviation 12.5
Insulin Levels for Intralipid/Dextrose Infusion Baseline	10.4 μU/mL Standard Deviation 9.6
Insulin Levels for Intralipid/Dextrose Infusion 8 hours	40.5 μU/mL Standard Deviation 22.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
C-peptides Levels for Saline Infusion Baseline	2.21 ng/mL Standard Deviation 1.04
C-peptides Levels for Saline Infusion 4 hours	2.06 ng/mL Standard Deviation 0.96
C-peptides Levels for Saline Infusion 8 hours	2.71 ng/mL Standard Deviation 1.36

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
C-peptides Levels for Intralipid Infusion Baseline	2.14 ng/mL Standard Deviation 1.12
C-peptides Levels for Intralipid Infusion 4 hours	2.39 ng/mL Standard Deviation 1.16
C-peptides Levels for Intralipid Infusion 8 hours	2.40 ng/mL Standard Deviation 1.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
C-peptides Levels for Dextrose Infusion Baseline	1.96 ng/mL Standard Deviation 1.58
C-peptides Levels for Dextrose Infusion 4 hours	4.73 ng/mL Standard Deviation 1.61
C-peptides Levels for Dextrose Infusion 8 hours	5.79 ng/mL Standard Deviation 2.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Subjects n=12 Participants 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
C-peptides Levels for Intralipid/Dextrose Infusion Baseline	2.23 ng/mL Standard Deviation 1.52
C-peptides Levels for Intralipid/Dextrose Infusion 4 hours	4.97 ng/mL Standard Deviation 1.74
C-peptides Levels for Intralipid/Dextrose Infusion 8 hours	6.43 ng/mL Standard Deviation 2.41

Adverse Events

Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: geumpie@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place