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Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier:
NCT00574340
First received: December 13, 2007
Last updated: February 9, 2017
Last verified: February 2017
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant;   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
Individuals were recruited to participate in a cross-over design coming in for a 2 day study with an 8 week wash out period and then returning for another 2 day study. Individuals were randomized in the order of completing the control group (day 1 euglycemia, day 2 hypoglycemia) or antecedent hypo group (day 1 hypoglycemia, day 2 hypoglycemia).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants completed both studies (either the control study (day 1 euglycemia, day 2 hypoglycemia) or the antecedent hypoglycemia study (day 1 hypoglycemia, day 2 hypoglycemia) in a random order with each study separated by an 8 week wash out period.

Reporting Groups
  Description
Control Study Then Antecedent Hypoglycemia Study Group Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
Antecedent Hypoglycemia Group Then Control Study Day 1 hypoglycemia, Day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, day 2 hypoglycemia

Participant Flow for 2 periods

Period 1:   Study 1 (2 Days)
    Control Study Then Antecedent Hypoglycemia Study Group   Antecedent Hypoglycemia Group Then Control Study
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 

Period 2:   Study 2 (2 Days)
    Control Study Then Antecedent Hypoglycemia Study Group   Antecedent Hypoglycemia Group Then Control Study
STARTED   6   6 
COMPLETED   6   6 
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
All Study Participants No text entered.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  40.0% 
Male      12  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      20 100.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2   [ Time Frame: baseline on day 2 and ~6 hours later at end of glucose clamp period ]


  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
No text entered.


  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


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: February 9, 2017