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Lifestyle Modification and Metformin Use in the Treatment of HIV

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ClinicalTrials.gov Identifier: NCT00399360
Recruitment Status : Completed
First Posted : November 14, 2006
Results First Posted : September 14, 2012
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (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

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

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

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

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

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

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

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

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

Measure Type Primary
Measure Title Coronary Artery Calcium Score
Measure Description Computed tomography (CT) imaging was performed using a SOMATOM Sensation (Siemens Medical Solutions, Forcheim, Germany) 64-slice CT scanner. Agatston calcium score was calculated using CT images. The total Agatston score is calculated by summing up the scores of the individual calcifications in all slices of the CT scan. An absolute Agatston score of less than 10 indicates minimal overall atherosclerosis (plaques) in the coronary arteries. The change in the coronary artery calcium score between baseline and 12 months is reported.
Time Frame baseline and 12 months  

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.
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.

Reporting Groups
  Description
No Lifestyle Modification and Placebo No text entered.
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 
Participants Analyzed 
[Units: Participants]
 		 11   10   10   11 
Coronary Artery Calcium Score 
[Units: Agatston score]
Mean (Standard Error) 		 43  (30)   19  (7)   1  (1)   -4  (6) 


Statistical Analysis 1 for Coronary Artery Calcium Score
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] 0.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.



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

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

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

10.  Secondary:   Intramyocellular Lipid   [ Time Frame: baseline and 12 months ]
  Show Outcome Measure 10


  Serious Adverse Events


  Other Adverse Events


  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
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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven Grinspoon, Principal Investigator
Organization: Massachusetts General Hospital
phone: 617-726-3890
e-mail: sgrinspoon@partners.org


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


Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00399360     History of Changes
Other Study ID Numbers: DK-49302-10AR
R01DK049302 ( U.S. NIH Grant/Contract )
First Submitted: November 13, 2006
First Posted: November 14, 2006
Results First Submitted: May 18, 2012
Results First Posted: September 14, 2012
Last Update Posted: September 14, 2012