This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: March 28, 2017
Last verified: March 2017
Results First Received: August 17, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Metabolic Syndrome X
Intervention: Biological: Endotoxin (LPS)

  Participant Flow
  Hide Participant Flow

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
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).


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



  Baseline Characteristics
  Hide Baseline Characteristics

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) 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Full Range)
 25.6 
 (19 to 40) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  46.0% 
Male      27  54.0% 


  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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
1R01HL073278-01 ( U.S. NIH Grant/Contract )
Study First Received: August 5, 2009
Results First Received: August 17, 2015
Last Updated: March 28, 2017