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ARREST PAD (Peripheral Arterial Disease)

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ClinicalTrials.gov Identifier: NCT00153166
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mark Alan Creager, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Arterial Occlusive Disease
Intermittent Claudication
Insulin Resistance
Interventions Drug: atorvastatin and pioglitazone
Drug: atorvastatin/placebo
Drug: pioglitazone/placebo
Drug: placebo/placebo
Enrollment 76
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Controls Patients With PAD PAD (Excluding Patients With Diabetes)
Hide Arm/Group Description Healthy individuals, non-smokers, normal CV examination. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo. 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. 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.
Period Title: Overall Study
Started 11 37 28
Received Atorvastatin and Pioglitazone 3 9 7
Received Atorvastatin and Placebo 2 9 7
Received Placebo and Pioglitazone 3 10 7
Received Placebo and Placebo 3 9 7
Completed 11 37 28
Not Completed 0 0 0
Arm/Group Title Healthy Controls Patients With PAD PAD Without Diabetes Total
Hide Arm/Group Description Healthy individuals, non-smokers, normal CV examination. Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes. Total of all reporting groups
Overall Number of Baseline Participants 11 37 28 76
Hide Baseline Analysis Population Description
Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants are grouped at Baseline regardless of randomization because we are measuring baseline characteristics that do not depend on which intervention they received.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 37 participants 28 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  27.3%
6
  16.2%
6
  21.4%
15
  19.7%
>=65 years
8
  72.7%
31
  83.8%
22
  78.6%
61
  80.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 37 participants 28 participants 76 participants
60.5  (6) 66  (8.7) 64.6  (8.8) 64.2  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 37 participants 28 participants 76 participants
Female
6
  54.5%
6
  16.2%
3
  10.7%
15
  19.7%
Male
5
  45.5%
31
  83.8%
25
  89.3%
61
  80.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 37 participants 28 participants 76 participants
11 37 28 76
1.Primary Outcome
Title Lower Extremity Skeletal Muscle Glucose Uptake
Hide Description Net calf skeletal muscle glucose uptake determined by Patlak modeling.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Healthy Controls Patients With PAD PAD (Excluding Diabetes)
Hide Arm/Group Description:
Healthy individuals, non-smokers, normal CV examination.
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
Overall Number of Participants Analyzed 11 37 28
Mean (Standard Deviation)
Unit of Measure: umol/kg/min
62.9  (21) 48.6  (15) 49.5  (3.1)
2.Secondary Outcome
Title 'M' = Whole Body Insulin Sensitivity
Hide Description 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.
Time Frame every 5 minutes for 20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Healthy Controls Patients With PAD PAD (Excluding Diabetes)
Hide Arm/Group Description:
Healthy individuals, non-smokers, normal CV examination.
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
Overall Number of Participants Analyzed 11 37 28
Median (Inter-Quartile Range)
Unit of Measure: mg/kg/min
5.0
(3.7 to 6.6)
3.4
(2.7 to 4.8)
3.4
(2.8 to 4.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Received Atorvastatin/Pioglitazone Received Atorvastatin/Placebo Received Placebo/Pioglitazone Received Placebo/Placebo
Hide Arm/Group Description Including healthy subjects and subjects with PAD Including healthy subjects and subjects with PAD Including healthy subjects and subjects with PAD Including healthy subjects and subjects with PAD
All-Cause Mortality
Received Atorvastatin/Pioglitazone Received Atorvastatin/Placebo Received Placebo/Pioglitazone Received Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Received Atorvastatin/Pioglitazone Received Atorvastatin/Placebo Received Placebo/Pioglitazone Received Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/18 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Received Atorvastatin/Pioglitazone Received Atorvastatin/Placebo Received Placebo/Pioglitazone Received Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/18 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
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: Mark Creager
Organization: Brigham and Women's Hospital
Phone: 617-732-5267
EMail: mcreager@partners.org
Layout table for additonal information
Responsible Party: Mark Alan Creager, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00153166    
Obsolete Identifiers: NCT00225940
Other Study ID Numbers: 2003P-001501
R01HL075771 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: April 24, 2013
Results First Posted: September 30, 2014
Last Update Posted: September 30, 2014