Trial Outcomes & Findings for Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease (NCT NCT01901224)
NCT ID: NCT01901224
Last Updated: 2018-09-24
Results Overview
PCr recovery time, measured in seconds, is a measure of skeletal muscle metabolic function. PCr is a transport molecule and reservoir of high-energy phosphate bonds, which is important for cellular energetics. Phosphocreatine regeneration depends upon the skeletal muscle mitochondrial cells capacity for oxidative phosphorylation. We will measure PCr recovery time at baseline and after 12 weeks of treatment with metformin or placebo as an in vivo measure of mitochondrial function. Higher Pcr relative to P(i) during recovery is better and shorter recovery times are better.
TERMINATED
PHASE4
2 participants
baseline, 12 weeks
2018-09-24
Participant Flow
Randomization blind was never broken, so only overall study participant flow is available.
Participant milestones
| Measure |
Overall Study
Overall Study (Metformin and Placebo arms combined)
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Overall Study
Overall Study (Metformin and Placebo arms combined)
|
|---|---|
|
Overall Study
study was not funded and terminated
|
2
|
Baseline Characteristics
Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease
Baseline characteristics by cohort
| Measure |
Overall Study
n=2 Participants
Overall Study (Metformin and Placebo arms combined)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Age, Continuous
|
79.5 years
STANDARD_DEVIATION 4.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.
PCr recovery time, measured in seconds, is a measure of skeletal muscle metabolic function. PCr is a transport molecule and reservoir of high-energy phosphate bonds, which is important for cellular energetics. Phosphocreatine regeneration depends upon the skeletal muscle mitochondrial cells capacity for oxidative phosphorylation. We will measure PCr recovery time at baseline and after 12 weeks of treatment with metformin or placebo as an in vivo measure of mitochondrial function. Higher Pcr relative to P(i) during recovery is better and shorter recovery times are better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.
Flow mediated vasodilation of the brachial artery is a measure of endothelium-dependent vasodilation. Higher flow-mediated dilation (FMD), measured as the diameter of the brachial artery in millimeters, and reported as percent change after a flow stimulus compered to basal measurement, is better, indicative of better endothelial function.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 weeksPopulation: Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.
Maximal treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 weeksPopulation: Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.
Pain-free treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 weeksPopulation: Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.
Oxygen consumption is measured in ml/kg/min. Higher values indicate better outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 12 weeksPopulation: Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.The 6 MWT is measured in meters, and higher values indicate better outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place