Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier:
NCT00574340
First received: December 13, 2007
Last updated: August 22, 2014
Last verified: August 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Type 2 Diabetes
Intervention: Other: Hyperinsulinemic Hypoglycemic Clamp

  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
Glucose Clamp

Day 1 euglycemia, day 2 hypoglycemia

Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks


Participant Flow:   Overall Study
    Glucose Clamp  
STARTED     28  
COMPLETED     28  
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.
No text entered.

Reporting Groups
  Description
Glucose Clamp

Day 1 euglycemia, day 2 hypoglycemia

Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks


Baseline Measures
    Glucose Clamp  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Mean ± Standard Deviation
  35  ± 1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     0  
Gender  
[units: participants]
 
Female     14  
Male     14  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     28  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures

1.  Primary:   Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound   [ Time Frame: 6 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: Dr. Stephen N. Davis
Organization: University of Maryland, Baltimore
phone: 410-328-2488
e-mail: sdavis@medicine.umaryland.edu


No publications provided by University of Maryland

Publications automatically indexed to this study:

Responsible Party: Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier: NCT00574340     History of Changes
Other Study ID Numbers: HP-00044875-SCCOR-Q4, RFAHL04016
Study First Received: December 13, 2007
Results First Received: May 27, 2014
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board