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Trial record 89 of 179 for:    Phospholipids

FFA-Induced Hypertension and Endothelial Dysfunction

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: NCT00589888
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : July 9, 2014
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Endothelial Dysfunction
Hypertension
Interventions Drug: Intralipid 20% @ 20cc/hour
Drug: Intralipid 20%@ 40cc/hour
Drug: Normal Saline
Dietary Supplement: 32-gram oral fat load
Dietary Supplement: 64-gram oral fat load
Enrollment 13
Recruitment Details  
Pre-assignment Details For this study, same 13 subjects were admitted to the General Clinical Research Center at Grady Memorial Hospital in random order on five different occasions to receive either 8-h iv or oral fat loads in either low or high doses or normal saline.
Arm/Group Title Normal Saline @ 40cc/Hour Intralipid 20% @ 20cc/hr Intralipid 20% @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Hide Arm/Group Description

Normal Saline continuous IV infusion at 40cc/hour for 8 hours

0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours

Intralipid 20% IV infusion at 20cc/hour

Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours

Intralipid 20% IV infusion at 40cc/hour

Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours

32-gram oral fat load

32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours.

64-gram oral fat load

64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours

Period Title: Normal Saline @ 40cc/Hour
Started 13 [1] 0 0 0 0
Completed 13 0 0 0 0
Not Completed 0 0 0 0 0
[1]
the same 13 patients did each of the 5 arms at 5 different visits
Period Title: Intralipid 20% @ 20cc/hr
Started 0 [1] 13 0 0 0
Completed 0 13 0 0 0
Not Completed 0 0 0 0 0
[1]
the same 13 patients did each of the 5 arms at 5 different visits
Period Title: Intralipid 20% @ 40cc/Hour
Started 0 0 [1] 13 [1] 0 0
Completed 0 0 13 0 0
Not Completed 0 0 0 0 0
[1]
the same 13 patients did each of the 5 arms at 5 different visits
Period Title: 32-gram Oral Fat Load
Started 0 0 0 [1] 13 [1] 0
Completed 0 0 0 13 0
Not Completed 0 0 0 0 0
[1]
the same 13 patients did each of the 5 arms at 5 different visits
Period Title: 64-gram Oral Fat Load
Started 0 0 0 0 [1] 13 [1]
Completed 0 0 0 0 13
Not Completed 0 0 0 0 0
[1]
the same 13 patients did each of the 5 arms at 5 different visits
Arm/Group Title All Study Participants
Hide Arm/Group Description

All participants received all 5 arms in random order:

  1. 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours
  2. Intralipid 20% @ 20cc/hr for 8 hours
  3. Intralipid 20% @ 40cc/Hr for 8 hours
  4. 32-gram Oral Fat Load every 2 hours for 8 hours.
  5. 64-gram Oral Fat Load every 2 hours for 8 hours.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
obese, healthy subjects. The same 13 participants received the interventions in random order on different occasions
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
32.2  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
9
  69.2%
Male
4
  30.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
12
  92.3%
White
1
   7.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Baseline Flow-mediated dilatation (FMD) of Brachial Artery   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 13 participants
9.4  (2.7)
[1]
Measure Description: FMD was assessed as a measurement of endothelial function. Ultrasound images of the brachial artery were obtained at baseline under standardized conditions and 60 s after induction of reactive hyperemia by 5-min cuff occlusion of the forearm. All images were digitized online, and arterial diameters were measured with customized software by individuals blinded to the clinical and laboratory status of the subjects. Flow-mediated dilatation (FMD) was expressed as the percentage increase in diameter from baseline. Itis measured in percentage
1.Primary Outcome
Title Change in Systolic Blood Pressure to After Completing an 8-hour Normal Saline Infusion in Obese Normotensive Subjects.
Hide Description To study the effects of high dose oral fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.
Time Frame Baseline and at the end of the 8-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline @ 40cc/Hour
Hide Arm/Group Description:

Normal Saline continuous IV infusion at 40cc/hour for 8 hours

0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmHg
13  (17)
2.Primary Outcome
Title Change in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 20cc/hr Infusion in Obese Normotensive Subjects.
Hide Description To study the effects of low dose intravenous (IV) fat infusion on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at every 2 hours till the end of infusion. The BP from the admission are compared to BP after the infusion.A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.
Time Frame Baseline and at the end of the 8-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid @ 20cc/Hour
Hide Arm/Group Description:
Intralipid continuous IV infusion at 20cc/hour for 8 hours
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmHg
14  (10)
3.Primary Outcome
Title Changes in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 40cc/hr Infusion in Obese Normotensive Subjects
Hide Description To study the effects of high dose intravenous (IV) fat infusion on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at every 2 hours till the end of infusion. The BP from the admission are compared to BP after the infusion. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.
Time Frame Baseline and at the end of the 8-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid @ 40cc/Hour for 8 Hours
Hide Arm/Group Description:
Intralipid continuous IV infusion at 40cc/hour for 8 hours
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmHg
12  (9)
4.Primary Outcome
Title Change in Systolic Blood Pressure From Baseline to After Completing an Oral 32-gram Fat Load in Obese Normotensive Subjects.
Hide Description To study the effects of oral low dose fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position.The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.
Time Frame Baseline and at the end of the 8-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral 32-gram Fat Load
Hide Arm/Group Description:
For the low (32 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmHg
13  (17)
5.Primary Outcome
Title Changes in Systolic Blood Pressure From Baseline to After Completing an Oral 64-gram Fat Load in Obese Normotensive Subjects
Hide Description To study the effects of high dose oral fat load on systolic blood pressure (SBP) in healthy obese subjects, subject's baseline SBP is compared to SBP after the infusion. Blood Pressure (BP) was measured with a manual cuff in triplicate on admission when patient was in Supine position. The Blood pressure was measured at admission and at end of the fat load. The BP from the admission are compared to BP after the fat load. A normal systolic blood pressure is lower than 120 mmHg; elevated blood pressure if the systolic reading is 120-129 mmHg. A level above 140 mmHg is considered hypertension.
Time Frame at the end of the 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral 64-gram Fat Load
Hide Arm/Group Description:
For the high (64 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mmHg
11  (11)
6.Secondary Outcome
Title Change in Flow-mediated Dilation (FMD) of Endothelium-dependent Brachial Artery From Baseline to After Completing a Specific Intervention in Obese Normotensive Subjects.
Hide Description Endothelium-dependent brachial artery dilatation was assessed as a measurement of endothelial function using established methodology. Briefly, ultrasound images of the brachial artery were obtained at baseline under standardized conditions and 60 s after induction of reactive hyperemia by 5-min cuff occlusion of the forearm. Image landmarks as well as surface markers were utilized to ensure anatomic consistency between serial imaging studies. All images were digitized online, and arterial diameters were measured with customized software by individuals blinded to the clinical and laboratory status of the subjects. Flow-mediated dilatation (FMD) was expressed as the percentage increase in diameter from baseline. It is measured in percentage.
Time Frame Baseline and at the end of the 8-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid 20%@ 20cc/Hour Intralipid 20% @ 40cc/Hour Normal Saline Infusion @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Hide Arm/Group Description:

Intralipid 20% IV infusion at 20cc/hour

Intralipid 20% @ 20cc/hour: In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting

Intralipid 20% IV infusion at 40cc/hour

Intralipid 20%@ 40cc/hour: In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting.

Normal Saline continuous IV infusion at 40cc/hour for 8 hours

Normal Saline: In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours.

32-gram oral fat load once

32-gram oral fat load: In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

64-gram oral fat load once

64-gram oral fat load: In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

Overall Number of Participants Analyzed 13 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: percentage of FMD
3.8  (2.1) 4.1  (3.1) 0.3  (0.1) 3.8  (1.8) 5  (2.5)
7.Secondary Outcome
Title Change in Blood Glucose Levels From Baseline to 6-8 Hours After Intervention Among Obese Healthy Subjects
Hide Description The blood glucose level is the amount of glucose present in the blood of humans. Many factors affect a person's blood sugar level. The body's homeostatic mechanism of blood sugar regulation (known as glucose homeostasis), when operating normally, restores the blood sugar level to a narrow range of about 4.4 to 6.1 mmol/L (79 to 110 mg/dL) (as measured by a fasting blood glucose test). The study aims to study the effects of these interventions on blood glucose levels among obese healthy subjects.
Time Frame Baseline and at the end of the 8-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid 20%@ 20cc/Hour Intralipid 20% @ 40cc/Hour Normal Saline Infusion @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Hide Arm/Group Description:

Intralipid 20% IV infusion at 20cc/hour

Intralipid 20% @ 20cc/hour: In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting

Intralipid 20% IV infusion at 40cc/hour

Intralipid 20%@ 40cc/hour: In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting.

Normal Saline continuous IV infusion at 40cc/hour for 8 hours

Normal Saline: In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours.

32-gram oral fat load once

32-gram oral fat load: In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

64-gram oral fat load once

64-gram oral fat load: In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

Overall Number of Participants Analyzed 13 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
baseline blood glucose level 93.9  (4.4) 92.3  (9.2) 91.5  (8.5) 91.5  (6.4) 87.1  (4.0)
After intervention blood glucose level 84.2  (5.7) 86.1  (8.1) 81.7  (7.2) 87.8  (7.8) 87.8  (10.3)
8.Secondary Outcome
Title Change in C-peptide Concentration Levels From Baseline to After Specific Intervention Among the Healthy Obese Subjects
Hide Description C-peptide is a peptide composed of 31 amino acids. It is released from the pancreatic beta-cells during cleavage of insulin from proinsulin. It is mainly excreted by the kidney, and its half-life is 3-4 times longer than that of insulin. The reference range of C-peptide is 0. 8-3 ng/ml. The C-peptide test is a tool to monitor and treat diabetes. It shows how well your body makes insulin, which moves sugar (or “glucose”) from your blood into your cells.
Time Frame baseline and after 8 hours after admission
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid 20%@ 20cc/Hour Intralipid 20% @ 40cc/Hour Normal Saline Infusion @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Hide Arm/Group Description:

Intralipid 20% IV infusion at 20cc/hour

Intralipid 20% @ 20cc/hour: In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting

Intralipid 20% IV infusion at 40cc/hour

Intralipid 20%@ 40cc/hour: In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting.

Normal Saline continuous IV infusion at 40cc/hour for 8 hours

Normal Saline: In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours.

32-gram oral fat load once

32-gram oral fat load: In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

64-gram oral fat load once

64-gram oral fat load: In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

Overall Number of Participants Analyzed 13 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: ng/ml
baseline C- Peptide 1.64  (0.84) 2.06  (0.69) 1.95  (0.87) 2.02  (0.59) 2.5  (0.41)
After intervention C- Peptide level 2.1  (1.08) 2.05  (0.62) 1.49  (0.63) 2.51  (0.78) 2.49  (1.03)
9.Secondary Outcome
Title Change in Blood Insulin Levels From Baseline to After Intervention Among the Normal Obese Subjects
Hide Description Insulin is an anabolic hormone that promotes glucose uptake, glycogenesis, lipogenesis, and protein synthesis of skeletal muscle and fat tissue through the tyrosine kinase receptor pathway. In addition, insulin is the most important factor in the regulation of plasma glucose homeostasis, as it counteracts glucagon and other catabolic hormones like epinephrine, glucocorticoid, and growth hormone. Normal fasting insulin levels is < 25 milli-International unit/litre
Time Frame Baseline and at the end of the 8-hours
Hide Outcome Measure Data
Hide Analysis Population Description
the same 13 subjects underwent different interventions in random order on different occasions
Arm/Group Title Intralipid 20%@ 20cc/Hour Intralipid 20% @ 40cc/Hour Normal Saline Infusion @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Hide Arm/Group Description:

Intralipid 20% IV infusion at 20cc/hour

Intralipid 20% @ 20cc/hour: In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting

Intralipid 20% IV infusion at 40cc/hour

Intralipid 20%@ 40cc/hour: In this arm subjects received Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours. In this arm subjects will receive Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid infusion studies, subjects remained fasting.

Normal Saline continuous IV infusion at 40cc/hour for 8 hours

Normal Saline: In this arm subjects received 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours.

32-gram oral fat load once

32-gram oral fat load: In this arm subjects received oral liquid fat load prepared by the General Clinical Research Center (GCRC) at baseline and every 2 hours for 6 hours. Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

64-gram oral fat load once

64-gram oral fat load: In this arm subjects received 60-gram oral fat load intake at baseline and every 2 hours for 6 hours prepared by the General Clinical Research Center (GCRC). Participants received fat with Free Fatty Acids (FFA) composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.

Overall Number of Participants Analyzed 13 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: milli-International unit /Litre
baseline blood insulin 8.5  (7.1) 9.2  (4.5) 8.8  (5) 7.8  (4.1) 9.1  (2.7)
After intervention blood insulin level 8.6  (5.7) 9.1  (4.4) 5.2  (3.5) 11.5  (6) 12.9  (9.4)
Time Frame From baseline (time of admission) to completing the intervention that is 8 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Saline @ 40cc/Hour Intralipid 20% @ 20cc/hr Intralipid 20% @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Hide Arm/Group Description

Normal Saline continuous IV infusion at 40cc/hour for 8 hours

0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours

Intralipid 20% IV infusion at 20cc/hour

Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours

Intralipid 20% IV infusion at 40cc/hour

Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours

32-gram oral fat load

32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours.

64-gram oral fat load

64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours

All-Cause Mortality
Normal Saline @ 40cc/Hour Intralipid 20% @ 20cc/hr Intralipid 20% @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Normal Saline @ 40cc/Hour Intralipid 20% @ 20cc/hr Intralipid 20% @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Saline @ 40cc/Hour Intralipid 20% @ 20cc/hr Intralipid 20% @ 40cc/Hour 32-gram Oral Fat Load 64-gram Oral Fat Load
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   1/13 (7.69%)   1/13 (7.69%)   0/13 (0.00%)   1/13 (7.69%) 
Gastrointestinal disorders           
indigestion * [1]  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/13 (7.69%) 
Vascular disorders           
venous irritation * [2]  0/13 (0.00%)  1/13 (7.69%)  1/13 (7.69%)  0/13 (0.00%)  0/13 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
temporary symptoms of reflux after ingesting the meal; no permanent sequelae or discontinuation
[2]
temporary irritation of vein towards the end of the 8-hour infusion; no permanent sequelae or discontinuation
The study subjects were mostly African-Americans, precluding generalization of the findings to other ethnic groups. Study was of short duration, and the composition of oral fat load was not identical to the intralipid composition.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Guillermo Umpierrez, MD
Organization: Emory Univ SOM
Phone: 4047781665
Responsible Party: Guillermo Umpierrez, MD, Emory University
ClinicalTrials.gov Identifier: NCT00589888     History of Changes
Other Study ID Numbers: IRB00041116
IRB 668-2006 ( Other Identifier: Other )
First Submitted: December 28, 2007
First Posted: January 10, 2008
Results First Submitted: March 24, 2014
Results First Posted: July 9, 2014
Last Update Posted: October 16, 2018