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FFA-Induced Hypertension and Endothelial Dysfunction

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00589888
First received: December 28, 2007
Last updated: June 6, 2014
Last verified: May 2014
Results First Received: March 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Endothelial Dysfunction
Hypertension
Interventions: Drug: Intralipid 20%
Drug: Normal Saline
Dietary Supplement: 32-gram oral fat load
Dietary Supplement: 64-gram oral fat load

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow for 5 periods

Period 1:   Normal Saline @ 40cc/Hour
    Normal Saline @ 40cc/Hour     Intralipid 20% @ 20cc/hr     Intralipid 20% @ 40cc/Hour     32-gram Oral Fat Load     64-gram Oral Fat Load  
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 2:   Intralipid 20% @ 20cc/hr
    Normal Saline @ 40cc/Hour     Intralipid 20% @ 20cc/hr     Intralipid 20% @ 40cc/Hour     32-gram Oral Fat Load     64-gram Oral Fat Load  
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 3:   Intralipid 20% @ 40cc/Hour
    Normal Saline @ 40cc/Hour     Intralipid 20% @ 20cc/hr     Intralipid 20% @ 40cc/Hour     32-gram Oral Fat Load     64-gram Oral Fat Load  
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 4:   32-gram Oral Fat Load
    Normal Saline @ 40cc/Hour     Intralipid 20% @ 20cc/hr     Intralipid 20% @ 40cc/Hour     32-gram Oral Fat Load     64-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 5:   64-gram Oral Fat Load
    Normal Saline @ 40cc/Hour     Intralipid 20% @ 20cc/hr     Intralipid 20% @ 40cc/Hour     32-gram Oral Fat Load     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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
obese, healthy subjects.

Reporting Groups
  Description
All Study 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 Loadevery 2 hours for 8 hours.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Mean ± Standard Deviation
  32.2  ± 9.8  
Gender  
[units: participants]
 
Female     9  
Male     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Systolic Blood Pressure   [ Time Frame: at the end of the 8-hours ]

2.  Primary:   Change in Systolic Blood Pressure   [ Time Frame: at the end of 8 hours ]

3.  Primary:   Changes in Systolic Blood Pressure   [ Time Frame: at the end of 8 hours ]

4.  Primary:   Changes in Systolic Blood Pressure From Baseline   [ Time Frame: at the end of 8 hours ]

5.  Primary:   Changes in Systolic Blood Pressure   [ Time Frame: at the end of the 8 hours ]

6.  Secondary:   The Secondary Outcomes of Interest Are the Effects of Increased FFAs on BP, Endothelial Function and Inflammatory Markers After Oral Fat Load (Chylomicron Pathway) Versus IV Administration of Intralipid Infusion in Obese Normotensive Subjects.   [ Time Frame: Changes in BP assessed every 2 hours during the 8 hours study; Lipid changes assessed every 2 hours during the 8-hour study, and Flow-mediated dilatation, peripheral compliance, PWA, and HRV assessed at 0,4, and 8 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
N/A


  More Information
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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
e-mail: geumpie@emory.edu


Publications of Results:

Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT00589888     History of Changes
Other Study ID Numbers: IRB00041116, IRB 668-2006
Study First Received: December 28, 2007
Results First Received: March 24, 2014
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board