Trial Outcomes & Findings for ARREST PAD (Peripheral Arterial Disease) (NCT NCT00153166)
NCT ID: NCT00153166
Last Updated: 2014-09-30
Results Overview
Net calf skeletal muscle glucose uptake determined by Patlak modeling.
COMPLETED
PHASE2/PHASE3
76 participants
60 minutes
2014-09-30
Participant Flow
Participant milestones
| Measure |
Healthy Controls
Healthy individuals, non-smokers, normal CV examination. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
|
Patients With PAD
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
|
PAD (Excluding Patients With Diabetes)
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Excluding those patients with diabetes. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
37
|
28
|
|
Overall Study
Received Atorvastatin and Pioglitazone
|
3
|
9
|
7
|
|
Overall Study
Received Atorvastatin and Placebo
|
2
|
9
|
7
|
|
Overall Study
Received Placebo and Pioglitazone
|
3
|
10
|
7
|
|
Overall Study
Received Placebo and Placebo
|
3
|
9
|
7
|
|
Overall Study
COMPLETED
|
11
|
37
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ARREST PAD (Peripheral Arterial Disease)
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=11 Participants
Healthy individuals, non-smokers, normal CV examination.
|
Patients With PAD
n=37 Participants
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
|
PAD Without Diabetes
n=28 Participants
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 6 • n=93 Participants
|
66 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
64.6 years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
64.2 years
STANDARD_DEVIATION 9.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
37 participants
n=4 Participants
|
28 participants
n=27 Participants
|
76 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.
Net calf skeletal muscle glucose uptake determined by Patlak modeling.
Outcome measures
| Measure |
Healthy Controls
n=11 Participants
Healthy individuals, non-smokers, normal CV examination.
|
Patients With PAD
n=37 Participants
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
|
PAD (Excluding Diabetes)
n=28 Participants
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
|
|---|---|---|---|
|
Lower Extremity Skeletal Muscle Glucose Uptake
|
62.9 umol/kg/min
Standard Deviation 21
|
48.6 umol/kg/min
Standard Deviation 15
|
49.5 umol/kg/min
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: every 5 minutes for 20 minutesPopulation: Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.
A hyperinsulinemic-euglycemic clamp was performed prior to and during FDG-PET imaging to measure insulin sensitivity and to standardize metabolic conditions. Subjects were required to fast for 8 hours prior to the study. Patients were given a primed insulin infusion of 2 mU/kg/min. Serum glucose measurements were made at five-minute intervals from an arterialized venous sample achieved by placing the hand in a warming box at 50°C. Blood glucose levels are checked every 5 minutes and 20% dextrose infusion is adjusted to maintain a serum glucose level of approximately 80 mg/dL. Subjects were considered to have achieved steady state when the dextrose infusion rate required to maintain a serum glucose level of 80 mg/dL varied by no greater than 5%. To compute the steady-state glucose disposal rate, we averaged the glucose infusion rates over the last 20 minutes of the clamp and applied a "space correction" to account for small changes in serum glucose levels over that time period.
Outcome measures
| Measure |
Healthy Controls
n=11 Participants
Healthy individuals, non-smokers, normal CV examination.
|
Patients With PAD
n=37 Participants
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
|
PAD (Excluding Diabetes)
n=28 Participants
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
|
|---|---|---|---|
|
'M' = Whole Body Insulin Sensitivity
|
5.0 mg/kg/min
Interval 3.7 to 6.6
|
3.4 mg/kg/min
Interval 2.7 to 4.8
|
3.4 mg/kg/min
Interval 2.8 to 4.9
|
Adverse Events
Received Atorvastatin/Pioglitazone
Received Atorvastatin/Placebo
Received Placebo/Pioglitazone
Received Placebo/Placebo
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