Inflammation and the Metabolic Syndrome in Humans (LPS)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00954824
First received: August 5, 2009
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: August 17, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Metabolic Syndrome X
Intervention: Biological: Endotoxin (LPS)

  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
Non-tobacco using individuals between ages 18-40 in 2 groups- with metabolic syndrome (having 3 of 5 criteria) and non-metabolic syndrome.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Endotoxin (LPS)

Single administration low-dose (3 ng/kg) endotoxin (LPS).

Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS).


Participant Flow:   Overall Study
    Endotoxin (LPS)  
STARTED     100  
COMPLETED     50  
NOT COMPLETED     50  



  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.
No text entered.

Reporting Groups
  Description
Endotoxin (LPS)

Single administration low-dose (3 ng/kg) endotoxin (LPS).

Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS).


Baseline Measures
    Endotoxin (LPS)  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean (Full Range)
  25.6   (19 to 40)  
Gender  
[units: participants]
 
Female     23  
Male     27  



  Outcome Measures

1.  Primary:   The Primary Outcome Measure is Plasma Levels of TNF Alpha.   [ Time Frame: 24 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
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  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: Muredach Reilly
Organization: UPenn
phone: 215-573-1214
e-mail: muredach@mail.med.upenn.edu


Publications:


Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00954824     History of Changes
Other Study ID Numbers: 706771
1RO1HL73278-01
Study First Received: August 5, 2009
Results First Received: August 17, 2015
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration