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The Effects of Metformin on Blood Vessel Structure and Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105066
First Posted: March 4, 2005
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
Results First Submitted: April 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Hypertension
Hypercholesterolemia
Hyperglycemia
Interventions: Drug: Metformin
Drug: Placebo

  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
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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
Placebo Placebo : placebo tablet once a day for one month, then twice a day for 3 months
Metformin Metformin : 850mg tablet once a day for one month, then twice a day for 3 months

Participant Flow:   Overall Study
    Placebo   Metformin
STARTED   27   50 
COMPLETED   25   45 
NOT COMPLETED   2   5 
Adverse Event                2                5 



  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.
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Reporting Groups
  Description
Placebo Placebo : placebo tablet once a day for one month, then twice a day for 3 months
Metformin Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
Total Total of all reporting groups

Baseline Measures
   Placebo   Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   49   76 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.6  (13.5)   55.1  (11.8)   54.4  (12.7) 
Gender 
[Units: Participants]
Count of Participants
     
Female      19  70.4%      34  69.4%      53  69.7% 
Male      8  29.6%      15  30.6%      23  30.3% 
Carotid Femoral Pulse Wave Velocity 
[Units: Meters/second]
Mean (Standard Deviation)
 6.8  (2.1)   6.8  (2.1)   6.8  (2.1) 
FMD [1] 
[Units: Percentage]
Mean (Standard Deviation)
 7.6  (4.4)   9.3  (6.1)   8.5  (5.3) 
[1] Flow Mediated Dilation of brachial artery (percent change in blood flow after hyperemia)
HOMA-S [1] 
[Units: HOMA Score]
Mean (Standard Deviation)
 52.9  (26.9)   52.3  (23.1)   52.5  (24.5) 
[1] HOMA Insulin Sensitivity Index


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Arterial Stiffness Compared to Baseline   [ Time Frame: Baseline and 4.5 months ]

2.  Primary:   Change in Flow Mediated Dilation (FMD)   [ Time Frame: Baseline and 4.5 months ]

3.  Post-Hoc:   Homa Insulin Sensitivity   [ Time Frame: 4.5 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. James Strait
Organization: National Institute On Aging
phone: 4105588084
e-mail: straitj@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00105066     History of Changes
Other Study ID Numbers: AG0017
First Submitted: March 3, 2005
First Posted: March 4, 2005
Results First Submitted: April 25, 2013
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017