Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
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
  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
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
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Carotid Intima Media Thickness
Measure Description Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement 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.
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 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.

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  
Carotid Intima Media Thickness  
[units: mm]
Mean ± Standard Error
  -0.02  ± 0.03     -0.02  ± 0.04     0.00  ± 0.01     0.03  ± 0.02  


Statistical Analysis 1 for Carotid Intima Media Thickness
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.37
[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.



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

Measure Type Primary
Measure Title Waist Circumference
Measure Description Iliac waist circumference measurements were obtained using an inelastic tape measure. All measurements were obtained in triplicate, with the patient undressed, and then averaged. The change of the waist circumference measurement 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.
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 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.

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  
Waist Circumference  
[units: cm]
Mean ± Standard Error
  -1.9  ± 1.4     -0.1  ± 1.7     0.3  ± 2.0     -1.4  ± 1.8  


Statistical Analysis 1 for Waist Circumference
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.80
[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.



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

Measure Type Primary
Measure Title High Density Lipoprotein (HDL)
Measure Description High density lipoprotein (HDL) was determined after an overnight fast. The change in HDL 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.
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 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.

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  
High Density Lipoprotein (HDL)  
[units: mg/dL]
Mean ± Standard Error
  -2  ± 1     2  ± 1     0  ± 2     4  ± 1  


Statistical Analysis 1 for High Density Lipoprotein (HDL)
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.08
[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.



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

Measure Type Primary
Measure Title Glucose
Measure Description Glucose level was determined after an overnight fast. The change in glucose 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  
Glucose  
[units: mg/dL]
Mean ± Standard Error
  -7  ± 5     3  ± 3     2  ± 2     -7  ± 3  


Statistical Analysis 1 for Glucose
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.13
[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.



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

Measure Type Primary
Measure Title Systolic Blood Pressure
Measure Description Systolic blood pressure was measured after 5 minutes rest. The in systolic blood pressure 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  
Systolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Error
  -5  ± 4     -2  ± 6     -2  ± 4     -6  ± 4  


Statistical Analysis 1 for Systolic Blood Pressure
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.85
[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.



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

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  
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.
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  
Number of 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
Method [2] ANOVA
P Value [3] 0.03
[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.



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

Measure Type Secondary
Measure Title C-reactive Protein
Measure Description High sensitivity C-reactive protein was determined by R&D Systems (Minneapolis, MN) kit. The change in C-reactive protein 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  
C-reactive Protein  
[units: mg/l]
Mean ± Standard Error
  -0.27  ± 0.66     -1.19  ± 1.11     0.47  ± 0.60     -1.92  ± 0.93  


Statistical Analysis 1 for C-reactive Protein
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.10
[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.



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

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 ]

Measure Type Secondary
Measure Title Cardiorespiratory Fitness
Measure Description A submaximal exercise stress test was conducted on a cycle ergometer to measure endurance. Subjects cycled between 50-60 revolutions per minute and the workload was progressively increased in increments of 50 watts in stages lasting 3 minutes. Once subjects became fatigued or reached their submaximal heart rate (220-age x 85), the test was stopped and separate readings of heart rate and blood pressure were measured at 1, 3, and 5 min of recovery. Weight-adjusted maximum oxygen consumption (VO2max; ml/kg per minute) was determined. The change in cardiorespiratory fitness 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.
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 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.

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  
Cardiorespiratory Fitness  
[units: ml/kg/min]
Mean ± Standard Error
  -0.7  ± 1.6     2.0  ± 1.2     -1.3  ± 0.9     3.7  ± 1.8  


Statistical Analysis 1 for Cardiorespiratory Fitness
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.05
[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.



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

Measure Type Secondary
Measure Title Intramyocellular Lipid
Measure Description Intramyocellular lipid (IMCL) of the tibialis anterior was determined using 1H-magnetic resonance spectroscopy (Siemens, Munich, Germany). The change in the intramyocellular lipid measurement 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  
Intramyocellular Lipid  
[units: mmol/kg]
Mean ± Standard Error
  0.6  ± 0.2     -0.4  ± 0.2     0.8  ± 0.4     0.1  ± 0.2  


Statistical Analysis 1 for Intramyocellular Lipid
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.02
[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.




  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
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