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Lifestyle Modification and Metformin Use in the Treatment of HIV

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
Results First Received: May 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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 ]
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2.  Primary:   Waist Circumference   [ Time Frame: baseline and 12 months ]
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3.  Primary:   High Density Lipoprotein (HDL)   [ Time Frame: baseline and 12 months ]
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4.  Primary:   Glucose   [ Time Frame: baseline and 12 months ]
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5.  Primary:   Systolic Blood Pressure   [ Time Frame: baseline and 12 months ]
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6.  Primary:   Coronary Artery Calcium Score   [ Time Frame: baseline and 12 months ]
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7.  Secondary:   C-reactive Protein   [ Time Frame: baseline and 12 months ]
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8.  Secondary:   Abdominal Visceral Adiposity   [ Time Frame: baseline and 12 months ]
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9.  Secondary:   Cardiorespiratory Fitness   [ Time Frame: baseline and 12 months ]
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10.  Secondary:   Intramyocellular Lipid   [ Time Frame: baseline and 12 months ]
  Show Outcome Measure 10


  Serious Adverse Events
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Time Frame 12 months
Additional Description safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked

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.

Serious Adverse Events
    No Lifestyle Modification and Placebo   Lifestyle Modification and Placebo   No Lifestyle Modification and Metformin   Lifestyle Modification and Metformin
Total, Serious Adverse Events         
# participants affected / at risk   0/11 (0.00%)   0/11 (0.00%)   0/13 (0.00%)   0/15 (0.00%) 




  Other Adverse Events
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  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
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