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Lifestyle Modification and Metformin Use in the Treatment of HIV

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00399360
First received: November 13, 2006
Last updated: September 13, 2012
Last verified: September 2012
Results First Received: May 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Metabolic Syndrome X
Interventions: Drug: Metformin
Drug: Placebo
Behavioral: Lifestyle Modification

  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
No Lifestyle Modification and Placebo Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Placebo Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
No Lifestyle Modification and Metformin Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Metformin Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.

Participant Flow:   Overall Study
    No Lifestyle Modification and Placebo     Lifestyle Modification and Placebo     No Lifestyle Modification and Metformin     Lifestyle Modification and Metformin  
STARTED     11     11     13     15  
COMPLETED     9     8     10     9  
NOT COMPLETED     2     3     3     6  
Lost to Follow-up                 2                 1                 2                 4  
Adverse Event                 0                 0                 1                 0  
Withdrawal by Subject                 0                 2                 0                 2  



  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
No Lifestyle Modification and Placebo Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Placebo Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
No Lifestyle Modification and Metformin Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Lifestyle Modification and Metformin Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
Total Total of all reporting groups

Baseline Measures
    No Lifestyle Modification and Placebo     Lifestyle Modification and Placebo     No Lifestyle Modification and Metformin     Lifestyle Modification and Metformin     Total  
Number of Participants  
[units: participants]
  11     11     13     15     50  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     11     11     13     15     50  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 6     49  ± 8     45  ± 9     47  ± 8     47  ± 7  
Gender  
[units: participants]
         
Female     4     3     3     2     12  
Male     7     8     10     13     38  
Race (NIH/OMB)  
[units: years]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     4     4     3     5     16  
White     7     6     9     10     32  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     1     0     0     1  
Region of Enrollment  
[units: participants]
         
United States     11     11     13     15     50  



  Outcome Measures
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1.  Primary:   Carotid Intima Media Thickness   [ Time Frame: baseline and 12 months ]

2.  Primary:   Waist Circumference   [ Time Frame: baseline and 12 months ]

3.  Primary:   High Density Lipoprotein (HDL)   [ Time Frame: baseline and 12 months ]

4.  Primary:   Glucose   [ Time Frame: baseline and 12 months ]

5.  Primary:   Systolic Blood Pressure   [ Time Frame: baseline and 12 months ]

6.  Primary:   Coronary Artery Calcium Score   [ Time Frame: baseline and 12 months ]

7.  Secondary:   C-reactive Protein   [ Time Frame: baseline and 12 months ]

8.  Secondary:   Abdominal Visceral Adiposity   [ Time Frame: baseline and 12 months ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Abdominal Visceral Adiposity
Measure Description Abdominal visceral adipose area was assess by magnetic resonance imaging at the lvel of the L4 pedicle. The change in abdominal visceral adiposity between baseline and 12 months is reported.
Time Frame baseline and 12 months  
Safety Issue No  

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
No Lifestyle Modification and Placebo All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
Lifestyle Modification and Placebo No text entered.
No Lifestyle Modification and Metformin No text entered.
Lifestyle Modification and Metformin No text entered.

Measured Values
    No Lifestyle Modification and Placebo     Lifestyle Modification and Placebo     No Lifestyle Modification and Metformin     Lifestyle Modification and Metformin  
Number of Participants Analyzed  
[units: participants]
  11     10     10     11  
Abdominal Visceral Adiposity  
[units: cm2]
Mean ± Standard Error
  -22.6  ± 14.5     -1.5  ± 14.0     -28.2  ± 15.3     -35.0  ± 27.7  


Statistical Analysis 1 for Abdominal Visceral Adiposity
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.63
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Secondary:   Cardiorespiratory Fitness   [ Time Frame: baseline and 12 months ]

10.  Secondary:   Intramyocellular Lipid   [ Time Frame: baseline and 12 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
The study was relatively small and may have been underpowered to assess effect on secondary endpoints and to assess the effects of lifestyle modification. The sample size may have limited our ability to determine differences in dropout rates.


  More Information