FFA Hypertension and Inflammation in Lean and Obese Subjects (FFAADA)

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00721617
First received: June 26, 2008
Last updated: July 23, 2015
Last verified: July 2015
Results First Received: May 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Diabetes
Hypertension
Obesity
Interventions: Other: Intralipid 20%
Other: Normal Saline
Other: 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
Subjects were recruited from Grady Memorial Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects had a 2-hour glucose of less than 200 mg/dL during a 75 g oral glucose tolerance test and a fasting glucose of less than 126 mg/dL.

Reporting Groups
  Description
Healthy Subjects Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h

Participant Flow for 12 periods

Period 1:   0 Hour (Baseline) of Saline Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 2:   4 Hours Into Saline Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 3:   8 Hours Into Saline Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 4:   0 Hour (Baseline) of Intralipid Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 5:   4 Hours Into Intralipid Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 6:   8 Hours Into Intralipid Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 7:   0 Hour (Baseline) of Dextrose Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 8:   4 Hours Into Dextrose Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 9:   8 Hours Into Dextrose Infusion
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 10:   0 Hour (Baseline) of Intralipid/Dextrose
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 11:   4 Hours Into Intralipid/Dextrose
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  

Period 12:   8 Hours Into Intralipid/Dextrose
    Healthy Subjects  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  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.
All subjects

Reporting Groups
  Description
Healthy Subjects Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h.

Baseline Measures
    Healthy Subjects  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Standard Deviation)
  41  (7)  
Gender  
[units: participants]
 
Female     5  
Male     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Flow-mediated Dilation From Baseline to 4 Hours   [ Time Frame: Baseline, 4 hours ]

2.  Primary:   Change in Systolic Blood Pressure From Baseline to 4 Hours   [ Time Frame: Baseline, 4 hours ]

3.  Primary:   Change in Systolic Blood Pressure From Baseline to 8 Hours   [ Time Frame: Baseline, 8 hours ]

4.  Primary:   Change in Diastolic Blood Pressure From Baseline to 4 Hours   [ Time Frame: Baseline, 4 hours ]

5.  Primary:   Change in Diastolic Blood Pressure From Baseline to 8 Hours   [ Time Frame: Baseline, 8 hours ]

6.  Secondary:   Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours   [ Time Frame: Baseline, 4 hours ]

7.  Secondary:   Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours   [ Time Frame: Baseline, 8 hours ]

8.  Secondary:   Change in Triglyceride Levels From Baseline to 4 Hours   [ Time Frame: Baseline, 4 hours ]

9.  Secondary:   Change in Triglyceride Levels From Baseline to 8 Hours   [ Time Frame: Baseline, 8 hours ]

10.  Secondary:   Plasma Glucose Levels for Saline Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

11.  Secondary:   Plasma Glucose Levels for Intralipid Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

12.  Secondary:   Plasma Glucose Levels for Dextrose Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

13.  Secondary:   Plasma Glucose Levels for Intralipid/Dextrose Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

14.  Secondary:   Insulin Levels for Saline Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

15.  Secondary:   Insulin Levels for Intralipid Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

16.  Secondary:   Insulin Levels for Dextrose Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

17.  Secondary:   Insulin Levels for Intralipid/Dextrose Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

18.  Secondary:   C-peptides Levels for Saline Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

19.  Secondary:   C-peptides Levels for Intralipid Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

20.  Secondary:   C-peptides Levels for Dextrose Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]

21.  Secondary:   C-peptides Levels for Intralipid/Dextrose Infusion   [ Time Frame: Baseline, 4 hours, 8 hours ]


  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
A larger sample size and inclusion of subjects from different ethnicities would be required to generalize the results of this study. Study used healthy volunteers--outcomes cannot be applied to patients with diabetes mellitus or insulin resistance


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Guillermo Umpierrez
Organization: Emory University
phone: 404-778-1665
e-mail: geumpie@emory.edu


No publications provided


Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT00721617     History of Changes
Other Study ID Numbers: IRB00009277
Study First Received: June 26, 2008
Results First Received: May 11, 2015
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board