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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Withdrawn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
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 2, 2009
    Last Updated
    July 2, 2014
    Sponsor
    Emory University
    Collaborators
    American Diabetes Association
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    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

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