The Effects of Metformin on Blood Vessel Structure and Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00105066
First received: March 3, 2005
Last updated: January 12, 2017
Last verified: January 2017
Results First Received: April 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Hypertension
Hypercholesterolemia
Hyperglycemia
Interventions: Drug: Metformin
Drug: Placebo

  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
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
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
  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
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
  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.