Treating the Endothelium to Restore Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00402194
First received: November 20, 2006
Last updated: September 20, 2013
Last verified: September 2013
Results First Received: May 6, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Insulin Resistance
Impaired Glucose Tolerance
Pre-diabetes
Intervention: Drug: Losartan

  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 by word of mouth and flyers posted in key locations on campus.

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
Treatment Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
Placebo Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.

Participant Flow:   Overall Study
    Treatment     Placebo  
STARTED     9     8  
COMPLETED     9     8  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Treatment Treatment with 100mg of losartan daily or placebo. Outcomes measured before and after 3 months of treatment.
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    Treatment     Placebo     Total  
Number of Participants  
[units: participants]
  9     8     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     8     17  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.0  ± 8.7     36.5  ± 10.1     38.8  ± 9.4  
Gender  
[units: participants]
     
Female     4     3     7  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     9     8     17  



  Outcome Measures
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1.  Primary:   Leg Blood Flow Response to Insulin   [ Time Frame: 3 months ]

2.  Primary:   Insulin-stimulated Leg Glucose Uptake   [ Time Frame: 3 months ]


  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:  
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: Dr. Kieren Mather
Organization: Indiana University
phone: 317-278-7826
e-mail: kmather@iu.edu


No publications provided


Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00402194     History of Changes
Other Study ID Numbers: IU-IRB-0301-08
Study First Received: November 20, 2006
Results First Received: May 6, 2013
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration