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Trial record 35 of 180 for:    Phospholipids

FFA Hypertension and Inflammation in Lean and Obese Subjects (FFAADA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00721617
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Diabetes
Hypertension
Obesity
Interventions Other: Intralipid 20%
Other: Normal Saline
Other: Oral fat load
Enrollment 12
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.
Arm/Group Title Healthy Subjects
Hide Arm/Group Description 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
Period Title: 0 Hour (Baseline) of Saline Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into Saline Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 8 Hours Into Saline Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 0 Hour (Baseline) of Intralipid Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into Intralipid Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 8 Hours Into Intralipid Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 0 Hour (Baseline) of Dextrose Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into Dextrose Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 8 Hours Into Dextrose Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 0 Hour (Baseline) of Intralipid/Dextrose
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into Intralipid/Dextrose
Started 12
Completed 12
Not Completed 0
Period Title: 8 Hours Into Intralipid/Dextrose
Started 12
Completed 12
Not Completed 0
Arm/Group Title Healthy Subjects
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
All subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
41  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
1.Primary Outcome
Title Change in Flow-mediated Dilation From Baseline to 4 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
Subjects received either IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) in a random order.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percent change in diameter
Saline 0.16  (4.9)
Intralipid 20% -3.2  (1.4)
Dextrose 10% -0.9  (1.8)
Intralipid/Dextrose -2.4  (2.1)
2.Primary Outcome
Title Change in Systolic Blood Pressure From Baseline to 4 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Error)
Unit of Measure: mmHg
Saline 1.92  (4.01)
Intralipid 20% 12.58  (2.1)
Dextrose 10% 3.00  (3.35)
Intralipid/Dextrose 1.91  (5.00)
3.Primary Outcome
Title Change in Systolic Blood Pressure From Baseline to 8 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Error)
Unit of Measure: mmHg
Saline 0.33  (4.89)
Intralipid 20% 12.08  (2.48)
Dextrose 10% 2.58  (3.09)
Intralipid/Dextrose 12.9  (6.62)
4.Primary Outcome
Title Change in Diastolic Blood Pressure From Baseline to 4 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmHg
Saline -1.25  (2.7)
Intralipid 20% 6.2  (2.35)
Dextrose 10% -2.08  (9.26)
Intralipid/Dextrose -4.27  (14.95)
5.Primary Outcome
Title Change in Diastolic Blood Pressure From Baseline to 8 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmHg
Saline 1.2  (10.5)
Intralipid 20% 4.8  (6.2)
Dextrose 10% -0.83  (9.7)
Intralipid/Dextrose 2.7  (9.0)
6.Secondary Outcome
Title Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/L
Saline -0.05  (0.27)
Intralipid 20% 0.84  (0.8)
Dextrose 10% -0.13  (0.43)
Intralipid/Dextrose -0.11  (0.48)
7.Secondary Outcome
Title Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mmol/L
Saline 0.03  (0.46)
Intralipid 20% 1.03  (1.1)
Dextrose 10% -0.18  (0.46)
Intralipid/Dextrose -0.1  (0.3)
8.Secondary Outcome
Title Change in Triglyceride Levels From Baseline to 4 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Error)
Unit of Measure: mg/dL
Saline -0.83  (37.7)
Intralipid 20% 118.9  (86.7)
Dextrose 10% -4.99  (51.2)
Intralipid/Dextrose 39.6  (30.56)
9.Secondary Outcome
Title Change in Triglyceride Levels From Baseline to 8 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Saline 2.1  (38.3)
Intralipid 20% 121.1  (96.8)
Dextrose 10% 3.98  (62.3)
Intralipid/Dextrose 47.3  (50.7)
10.Secondary Outcome
Title Plasma Glucose Levels for Saline Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 86.0  (9.6)
4 hours 87.0  (20.7)
8 hours 88.0  (15.0)
11.Secondary Outcome
Title Plasma Glucose Levels for Intralipid Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 78.4  (8.0)
4 hours 75.6  (9.4)
8 hours 73.7  (10.6)
12.Secondary Outcome
Title Plasma Glucose Levels for Dextrose Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 77.4  (12.4)
4 hours 100.4  (19.5)
8 hours 93.0  (13.9)
13.Secondary Outcome
Title Plasma Glucose Levels for Intralipid/Dextrose Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 71.6  (12.3)
4 hours 101.2  (16.6)
8 hours 97.8  (11.1)
14.Secondary Outcome
Title Insulin Levels for Saline Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: μU/mL
Baseline 8.4  (4.9)
4 hours 11.3  (6.4)
8 hours 10.1  (6.6)
15.Secondary Outcome
Title Insulin Levels for Intralipid Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: μU/mL
Baseline 9.1  (5.5)
4 hours 11.3  (7.7)
8 hours 9.3  (7.5)
16.Secondary Outcome
Title Insulin Levels for Dextrose Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: μU/mL
Baseline 8.4  (9.6)
4 hours 25.1  (10.2)
8 hours 33.4  (21.0)
17.Secondary Outcome
Title Insulin Levels for Intralipid/Dextrose Infusion
Hide Description 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.
Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: μU/mL
Baseline 10.4  (9.6)
4 hours 28.0  (12.5)
8 hours 40.5  (22.8)
18.Secondary Outcome
Title C-peptides Levels for Saline Infusion
Hide Description

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.

Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 2.21  (1.04)
4 hours 2.06  (0.96)
8 hours 2.71  (1.36)
19.Secondary Outcome
Title C-peptides Levels for Intralipid Infusion
Hide Description

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.

Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 2.14  (1.12)
4 hours 2.39  (1.16)
8 hours 2.40  (1.23)
20.Secondary Outcome
Title C-peptides Levels for Dextrose Infusion
Hide Description

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.

Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 1.96  (1.58)
4 hours 4.73  (1.61)
8 hours 5.79  (2.08)
21.Secondary Outcome
Title C-peptides Levels for Intralipid/Dextrose Infusion
Hide Description

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.

Time Frame Baseline, 4 hours, 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 2.23  (1.52)
4 hours 4.97  (1.74)
8 hours 6.43  (2.41)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Subjects
Hide Arm/Group Description 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
All-Cause Mortality
Healthy Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Subjects
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Healthy Subjects
Affected / at Risk (%)
Total   0/12 (0.00%) 
A larger sample size and inclusion of subjects from different ethnicities would be required to generalize the results of this study. Study used healthy volunteers--outcomes cannot be applied to patients with diabetes mellitus or insulin resistance
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Guillermo Umpierrez
Organization: Emory University
Phone: 404-778-1665
Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT00721617     History of Changes
Other Study ID Numbers: IRB00009277
First Submitted: June 26, 2008
First Posted: July 24, 2008
Results First Submitted: May 11, 2015
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015