Effects of Intralipid Versus Olive Oil Infusions on Endothelial Function, Immune Function, Inflammatory Markers
Primary Purpose
Diabetes, Hypertension, Obesity
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Twenty-four Hour TPN and Saline Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring lipid emulsion, endothelial function, inflammatory markers, oxidative stress, insulin sensitivity, carbohydrate metabolism
Eligibility Criteria
Inclusion Criteria:
- Healthy males or females
- BMI 25 -35 kg/m2, between the ages of 18 and 65 years
- BP < 140/80 mm Hg and no prior history of hypertension
Exclusion Criteria:
- Pregnancy or breast feeding
- History of diabetes, hypertension, fasting triglyceride levels > 250 mg/dL, liver disease (ALT 2.5x > upper limit of normal), serum creatinine ≥ 1.5 mg/dL, -Smokers or ex-smoker < 3 months of cessation, drug or alcohol abuse
- Mental condition rendering the subject unable to understand the scope and possible consequences of the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Twenty-four Hour TPN and Saline Infusion
Arm Description
Subjects will be admitted to the Grady research center on the evening before each study. The next morning, after an overnight fast, they will receive, in random order, Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr. The interval between admissions will be 1 month.
Outcomes
Primary Outcome Measures
endothelial function
Secondary Outcome Measures
oxidative stress
autonomic nervous system
insulin sensitivity
carbohydrate metabolism
Full Information
NCT ID
NCT00989339
First Posted
October 2, 2009
Last Updated
July 2, 2014
Sponsor
Emory University
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT00989339
Brief Title
Effects of Intralipid Versus Olive Oil Infusions on Endothelial Function, Immune Function, Inflammatory Markers
Official Title
Effects of Intralipid and Olive Oil Infusion on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Sub-investigator left facility prior to study initiation
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
American Diabetes Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Recent evidence suggests that increased levels of a circulation fat (free fatty acids or FFAs) can cause high blood pressure and cardiac complications. Intralipid is the only type of fat approved by the FDA for clinical use. It is usually used as nutrition support in malnourished patients. The investigators' preliminary studies indicate that Intralipid results in a significant rise in blood pressure, blood vessel stiffness, and inflammation in obese subjects. Olive oil can also be used as nutrition support. The effect of olive oil intravenous (IV) on blood pressure and inflammation is not known. In this study, the investigators will compare the effect of Intralipid and olive oil on blood pressure, blood vessel stiffness and inflammation in healthy subjects. The investigators hypothesize that Olive oil emulsions will result in less vascular changes and less inflammatory response than Intralipid solutions. Accordingly, the investigators propose a systematic evaluation of the effects of Intralipid, olive oil and normal saline on blood pressure, endothelial function (vascular stiffness), inflammation in normal subjects.
A group of obese subjects will be admitted to the Clinical Research Center on 3 occasions. Subjects will receive repeated infusions of Intralipid, ClinOleic, and normal saline at 20 ml/hour for 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Obesity
Keywords
lipid emulsion, endothelial function, inflammatory markers, oxidative stress, insulin sensitivity, carbohydrate metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Twenty-four Hour TPN and Saline Infusion
Arm Type
Experimental
Arm Description
Subjects will be admitted to the Grady research center on the evening before each study. The next morning, after an overnight fast, they will receive, in random order, Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr. The interval between admissions will be 1 month.
Intervention Type
Drug
Intervention Name(s)
Twenty-four Hour TPN and Saline Infusion
Intervention Description
Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.
Primary Outcome Measure Information:
Title
endothelial function
Time Frame
1 year
Secondary Outcome Measure Information:
Title
oxidative stress
Time Frame
1 year
Title
autonomic nervous system
Time Frame
1 year
Title
insulin sensitivity
Time Frame
1 year
Title
carbohydrate metabolism
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy males or females
BMI 25 -35 kg/m2, between the ages of 18 and 65 years
BP < 140/80 mm Hg and no prior history of hypertension
Exclusion Criteria:
Pregnancy or breast feeding
History of diabetes, hypertension, fasting triglyceride levels > 250 mg/dL, liver disease (ALT 2.5x > upper limit of normal), serum creatinine ≥ 1.5 mg/dL, -Smokers or ex-smoker < 3 months of cessation, drug or alcohol abuse
Mental condition rendering the subject unable to understand the scope and possible consequences of the study
12. IPD Sharing Statement
Learn more about this trial
Effects of Intralipid Versus Olive Oil Infusions on Endothelial Function, Immune Function, Inflammatory Markers
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