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Lifestyle Modification and Metformin Use in the Treatment of HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 11 11 13 15
Completed 9 8 10 9
Not Completed 2 3 3 6
Reason Not Completed
Lost to Follow-up             2             1             2             4
Adverse Event             0             0             1             0
Withdrawal by Subject             0             2             0             2
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 11 11 13 15 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 13 participants 15 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
11
 100.0%
13
 100.0%
15
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 13 participants 15 participants 50 participants
47  (6) 49  (8) 45  (9) 47  (8) 47  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 13 participants 15 participants 50 participants
Female
4
  36.4%
3
  27.3%
3
  23.1%
2
  13.3%
12
  24.0%
Male
7
  63.6%
8
  72.7%
10
  76.9%
13
  86.7%
38
  76.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 13 participants 15 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   7.7%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  36.4%
4
  36.4%
3
  23.1%
5
  33.3%
16
  32.0%
White
7
  63.6%
6
  54.5%
9
  69.2%
10
  66.7%
32
  64.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
1
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 13 participants 15 participants 50 participants
11 11 13 15 50
1.Primary Outcome
Title Carotid Intima Media Thickness
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: mm
-0.02  (0.03) -0.02  (0.04) 0.00  (0.01) 0.03  (0.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Waist Circumference
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: cm
-1.9  (1.4) -0.1  (1.7) 0.3  (2.0) -1.4  (1.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title High Density Lipoprotein (HDL)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: mg/dL
-2  (1) 2  (1) 0  (2) 4  (1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Glucose
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: mg/dL
-7  (5) 3  (3) 2  (2) -7  (3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Systolic Blood Pressure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: mm Hg
-5  (4) -2  (6) -2  (4) -6  (4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Coronary Artery Calcium Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: Agatston score
43  (30) 19  (7) 1  (1) -4  (6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title C-reactive Protein
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: mg/l
-0.27  (0.66) -1.19  (1.11) 0.47  (0.60) -1.92  (0.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Abdominal Visceral Adiposity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: cm2
-22.6  (14.5) -1.5  (14.0) -28.2  (15.3) -35.0  (27.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Cardiorespiratory Fitness
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: ml/kg/min
-0.7  (1.6) 2.0  (1.2) -1.3  (0.9) 3.7  (1.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Intramyocellular Lipid
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description:
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.
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 10 10 11
Mean (Standard Error)
Unit of Measure: mmol/kg
0.6  (0.2) -0.4  (0.2) 0.8  (0.4) 0.1  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Lifestyle Modification and Placebo, Lifestyle Modification and Placebo, No Lifestyle Modification and Metformin, Lifestyle Modification and Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
 
Arm/Group Title No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)      0/13 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Lifestyle Modification and Placebo Lifestyle Modification and Placebo No Lifestyle Modification and Metformin Lifestyle Modification and Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      2/11 (18.18%)      3/13 (23.08%)      5/15 (33.33%)    
Gastrointestinal disorders         
Diarrhea  1  0/11 (0.00%)  0 0/11 (0.00%)  0 3/13 (23.08%)  3 3/15 (20.00%)  3
Musculoskeletal and connective tissue disorders         
Muscle strain  1  0/11 (0.00%)  0 0/11 (0.00%)  0 0/13 (0.00%)  0 2/15 (13.33%)  2
Renal and urinary disorders         
elevated creatinine  1  0/11 (0.00%)  0 2/11 (18.18%)  2 0/13 (0.00%)  0 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Grinspoon, Principal Investigator
Organization: Massachusetts General Hospital
Phone: 617-726-3890
EMail: sgrinspoon@partners.org
Layout table for additonal information
Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00399360    
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