Trial Outcomes & Findings for FFA-Induced Hypertension and Endothelial Dysfunction (NCT NCT00589888)

Last Updated: 2018-10-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Baseline and at the end of the 8-hours

Results posted on

2018-10-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Normal Saline @ 40cc/Hour 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% @ 20cc/hr Intralipid 20% IV infusion at 20cc/hour Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours	Intralipid 20% @ 40cc/Hour 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 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 64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours
Normal Saline @ 40cc/Hour STARTED	13	0	0	0	0
Normal Saline @ 40cc/Hour COMPLETED	13	0	0	0	0
Normal Saline @ 40cc/Hour NOT COMPLETED	0	0	0	0	0
Intralipid 20% @ 20cc/hr STARTED	0	13	0	0	0
Intralipid 20% @ 20cc/hr COMPLETED	0	13	0	0	0
Intralipid 20% @ 20cc/hr NOT COMPLETED	0	0	0	0	0
Intralipid 20% @ 40cc/Hour STARTED	0	0	13	0	0
Intralipid 20% @ 40cc/Hour COMPLETED	0	0	13	0	0
Intralipid 20% @ 40cc/Hour NOT COMPLETED	0	0	0	0	0
32-gram Oral Fat Load STARTED	0	0	0	13	0
32-gram Oral Fat Load COMPLETED	0	0	0	13	0
32-gram Oral Fat Load NOT COMPLETED	0	0	0	0	0
64-gram Oral Fat Load STARTED	0	0	0	0	13
64-gram Oral Fat Load COMPLETED	0	0	0	0	13
64-gram Oral Fat Load NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FFA-Induced Hypertension and Endothelial Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=13 Participants 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.
Age, Continuous	32.2 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Baseline Flow-mediated dilatation (FMD) of Brachial Artery	9.4 percentage STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at the end of the 8-hours

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour 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 Infusion @ 40cc/Hour 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 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 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.
Change in Systolic Blood Pressure to After Completing an 8-hour Normal Saline Infusion in Obese Normotensive Subjects.	13 mmHg Standard Deviation 17	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and at the end of the 8-hours

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.

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour 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 Infusion @ 40cc/Hour 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 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 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.
Change in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 20cc/hr Infusion in Obese Normotensive Subjects.	14 mmHg Standard Deviation 10	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and at the end of the 8-hours

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.

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour 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 Infusion @ 40cc/Hour 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 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 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.
Changes in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 40cc/hr Infusion in Obese Normotensive Subjects	12 mmHg Standard Deviation 9	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and at the end of the 8-hours

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.

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour 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 Infusion @ 40cc/Hour 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 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 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.
Change in Systolic Blood Pressure From Baseline to After Completing an Oral 32-gram Fat Load in Obese Normotensive Subjects.	13 mmHg Standard Deviation 17	—	—	—	—

PRIMARY outcome

Timeframe: at the end of the 8 hours

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour 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 Infusion @ 40cc/Hour 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 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 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.
Changes in Systolic Blood Pressure From Baseline to After Completing an Oral 64-gram Fat Load in Obese Normotensive Subjects	11 mmHg Standard Deviation 11	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and at the end of the 8-hours

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.

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour n=13 Participants 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 Infusion @ 40cc/Hour n=13 Participants 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 n=13 Participants 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 n=13 Participants 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.
Change in Flow-mediated Dilation (FMD) of Endothelium-dependent Brachial Artery From Baseline to After Completing a Specific Intervention in Obese Normotensive Subjects.	3.8 percentage of FMD Standard Deviation 2.1	4.1 percentage of FMD Standard Deviation 3.1	0.3 percentage of FMD Standard Deviation 0.1	3.8 percentage of FMD Standard Deviation 1.8	5 percentage of FMD Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline and at the end of the 8-hours

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.

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour n=13 Participants 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 Infusion @ 40cc/Hour n=13 Participants 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 n=13 Participants 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 n=13 Participants 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.
Change in Blood Glucose Levels From Baseline to 6-8 Hours After Intervention Among Obese Healthy Subjects After intervention blood glucose level	84.2 mg/dL Standard Deviation 5.7	86.1 mg/dL Standard Deviation 8.1	81.7 mg/dL Standard Deviation 7.2	87.8 mg/dL Standard Deviation 7.8	87.8 mg/dL Standard Deviation 10.3
Change in Blood Glucose Levels From Baseline to 6-8 Hours After Intervention Among Obese Healthy Subjects baseline blood glucose level	93.9 mg/dL Standard Deviation 4.4	92.3 mg/dL Standard Deviation 9.2	91.5 mg/dL Standard Deviation 8.5	91.5 mg/dL Standard Deviation 6.4	87.1 mg/dL Standard Deviation 4.0

SECONDARY outcome

Timeframe: baseline and after 8 hours after admission

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.

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour n=13 Participants 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 Infusion @ 40cc/Hour n=13 Participants 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 n=13 Participants 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 n=13 Participants 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.
Change in C-peptide Concentration Levels From Baseline to After Specific Intervention Among the Healthy Obese Subjects baseline C- Peptide	1.64 ng/ml Standard Deviation 0.84	2.06 ng/ml Standard Deviation 0.69	1.95 ng/ml Standard Deviation 0.87	2.02 ng/ml Standard Deviation 0.59	2.5 ng/ml Standard Deviation 0.41
Change in C-peptide Concentration Levels From Baseline to After Specific Intervention Among the Healthy Obese Subjects After intervention C- Peptide level	2.1 ng/ml Standard Deviation 1.08	2.05 ng/ml Standard Deviation 0.62	1.49 ng/ml Standard Deviation 0.63	2.51 ng/ml Standard Deviation 0.78	2.49 ng/ml Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline and at the end of the 8-hours

Population: the same 13 subjects underwent different interventions in random order on different occasions

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

Outcome measures

Outcome measures
Measure	Normal Saline @ 40cc/Hour n=13 Participants 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% @ 40cc/Hour n=13 Participants 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 Infusion @ 40cc/Hour n=13 Participants 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 n=13 Participants 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 n=13 Participants 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.
Change in Blood Insulin Levels From Baseline to After Intervention Among the Normal Obese Subjects baseline blood insulin	8.5 milli-International unit /Litre Standard Deviation 7.1	9.2 milli-International unit /Litre Standard Deviation 4.5	8.8 milli-International unit /Litre Standard Deviation 5	7.8 milli-International unit /Litre Standard Deviation 4.1	9.1 milli-International unit /Litre Standard Deviation 2.7
Change in Blood Insulin Levels From Baseline to After Intervention Among the Normal Obese Subjects After intervention blood insulin level	8.6 milli-International unit /Litre Standard Deviation 5.7	9.1 milli-International unit /Litre Standard Deviation 4.4	5.2 milli-International unit /Litre Standard Deviation 3.5	11.5 milli-International unit /Litre Standard Deviation 6	12.9 milli-International unit /Litre Standard Deviation 9.4

Adverse Events

Normal Saline @ 40cc/Hour

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intralipid 20% @ 20cc/hr

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intralipid 20% @ 40cc/Hour

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

32-gram Oral Fat Load

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

64-gram Oral Fat Load

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Normal Saline @ 40cc/Hour n=13 participants at risk 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% @ 20cc/hr n=13 participants at risk Intralipid 20% IV infusion at 20cc/hour Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours	Intralipid 20% @ 40cc/Hour n=13 participants at risk 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 n=13 participants at risk 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 n=13 participants at risk 64-gram oral fat load 64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours
Vascular disorders venous irritation	0.00% 0/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	7.7% 1/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	7.7% 1/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	0.00% 0/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	0.00% 0/13 • From baseline (time of admission) to completing the intervention that is 8 hours.
Gastrointestinal disorders indigestion	0.00% 0/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	0.00% 0/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	0.00% 0/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	0.00% 0/13 • From baseline (time of admission) to completing the intervention that is 8 hours.	7.7% 1/13 • From baseline (time of admission) to completing the intervention that is 8 hours.

Additional Information

Guillermo Umpierrez, MD

Emory Univ SOM

Phone: 4047781665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place