Trial Outcomes & Findings for Lifestyle Modification and Metformin Use in the Treatment of HIV (NCT NCT00399360)
NCT ID: NCT00399360
Last Updated: 2012-09-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
baseline and 12 months
Results posted on
2012-09-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
13
|
15
|
|
Overall Study
COMPLETED
|
9
|
8
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
4
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
2
|
Baseline Characteristics
Lifestyle Modification and Metformin Use in the Treatment of HIV
Baseline characteristics by cohort
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=11 Participants
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
n=13 Participants
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
n=15 Participants
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
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
47 years
STANDARD_DEVIATION 6 • n=5 Participants
|
49 years
STANDARD_DEVIATION 8 • n=7 Participants
|
45 years
STANDARD_DEVIATION 9 • n=5 Participants
|
47 years
STANDARD_DEVIATION 8 • n=4 Participants
|
47 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
13 participants
n=5 Participants
|
15 participants
n=4 Participants
|
50 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Carotid Intima Media Thickness
|
-0.02 mm
Standard Error 0.03
|
-0.02 mm
Standard Error 0.04
|
0.00 mm
Standard Error 0.01
|
0.03 mm
Standard Error 0.02
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Waist Circumference
|
-1.9 cm
Standard Error 1.4
|
-0.1 cm
Standard Error 1.7
|
0.3 cm
Standard Error 2.0
|
-1.4 cm
Standard Error 1.8
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: 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.
High density lipoprotein (HDL) was determined after an overnight fast. The change in HDL between baseline and 12 months is reported.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
High Density Lipoprotein (HDL)
|
-2 mg/dL
Standard Error 1
|
2 mg/dL
Standard Error 1
|
0 mg/dL
Standard Error 2
|
4 mg/dL
Standard Error 1
|
PRIMARY outcome
Timeframe: baseline and 12 monthsGlucose level was determined after an overnight fast. The change in glucose between baseline and 12 months is reported.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Glucose
|
-7 mg/dL
Standard Error 5
|
3 mg/dL
Standard Error 3
|
2 mg/dL
Standard Error 2
|
-7 mg/dL
Standard Error 3
|
PRIMARY outcome
Timeframe: baseline and 12 monthsSystolic blood pressure was measured after 5 minutes rest. The in systolic blood pressure between baseline and 12 months is reported.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Systolic Blood Pressure
|
-5 mm Hg
Standard Error 4
|
-2 mm Hg
Standard Error 6
|
-2 mm Hg
Standard Error 4
|
-6 mm Hg
Standard Error 4
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Coronary Artery Calcium Score
|
43 Agatston score
Standard Error 30
|
19 Agatston score
Standard Error 7
|
1 Agatston score
Standard Error 1
|
-4 Agatston score
Standard Error 6
|
SECONDARY outcome
Timeframe: baseline and 12 monthsHigh 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.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
C-reactive Protein
|
-0.27 mg/l
Standard Error 0.66
|
-1.19 mg/l
Standard Error 1.11
|
0.47 mg/l
Standard Error 0.60
|
-1.92 mg/l
Standard Error 0.93
|
SECONDARY outcome
Timeframe: baseline and 12 monthsAbdominal 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.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Abdominal Visceral Adiposity
|
-22.6 cm2
Standard Error 14.5
|
-1.5 cm2
Standard Error 14.0
|
-28.2 cm2
Standard Error 15.3
|
-35.0 cm2
Standard Error 27.7
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Cardiorespiratory Fitness
|
-0.7 ml/kg/min
Standard Error 1.6
|
2.0 ml/kg/min
Standard Error 1.2
|
-1.3 ml/kg/min
Standard Error 0.9
|
3.7 ml/kg/min
Standard Error 1.8
|
SECONDARY outcome
Timeframe: baseline and 12 monthsIntramyocellular 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.
Outcome measures
| Measure |
No Lifestyle Modification and Placebo
n=11 Participants
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
n=10 Participants
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
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|
|
Intramyocellular Lipid
|
0.6 mmol/kg
Standard Error 0.2
|
-0.4 mmol/kg
Standard Error 0.2
|
0.8 mmol/kg
Standard Error 0.4
|
0.1 mmol/kg
Standard Error 0.2
|
Adverse Events
No Lifestyle Modification and Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifestyle Modification and Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
No Lifestyle Modification and Metformin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lifestyle Modification and Metformin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
No Lifestyle Modification and Placebo
n=11 participants at risk
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
n=11 participants at risk
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
n=13 participants at risk
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
n=15 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
0.00%
0/11 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
23.1%
3/13 • Number of events 3 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
20.0%
3/15 • Number of events 3 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/11 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
0.00%
0/11 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
0.00%
0/13 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
13.3%
2/15 • Number of events 2 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
|
Renal and urinary disorders
elevated creatinine
|
0.00%
0/11 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
18.2%
2/11 • Number of events 2 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
0.00%
0/13 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
0.00%
0/15 • 12 months
safety visits occurred at 1, 3, 6, and 9 months during which time ALT, creatinine, lactate level and CBC were checked
|
Additional Information
Dr. Steven Grinspoon, Principal Investigator
Massachusetts General Hospital
Phone: 617-726-3890
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place