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Trial · NCT00153166

ARREST PAD (Peripheral Arterial Disease)

NCT00153166, Phase 2, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2014-09-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. ARREST PAD (Peripheral Arterial Disease). Trials, record NCT00153166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00153166

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
ARREST PAD (Peripheral Arterial Disease)
NCT number
NCT00153166
Status
Completed
Phases
Phase 2, Phase 3
Enrollment
76 participants, actual
Lead sponsor
Brigham and Women's Hospital
Conditions
Arterial Occlusive Disease, Intermittent Claudication, Insulin Resistance
Interventions
atorvastatin and pioglitazone, atorvastatin/placebo, pioglitazone/placebo, placebo/placebo
First posted
2005-09-12
Last updated
2014-09-30
Results first posted
2014-09-30

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryLower Extremity Skeletal Muscle Glucose Uptake60 minutesNet calf skeletal muscle glucose uptake determined by Patlak modeling.
Secondary'M' = Whole Body Insulin Sensitivityevery 5 minutes for 20 minutes
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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYLower Extremity Skeletal Muscle Glucose Uptake60 minutes
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.
umol/kg/minMEAN
SECONDARY'M' = Whole Body Insulin Sensitivityevery 5 minutes for 20 minutes
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.
mg/kg/minMEDIAN

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Lower Extremity Skeletal Muscle Glucose UptakeHealthy Controls62.9Standard Deviation 21umol/kg/min
Lower Extremity Skeletal Muscle Glucose UptakePatients With PAD48.6Standard Deviation 15umol/kg/min
Lower Extremity Skeletal Muscle Glucose UptakePAD (Excluding Diabetes)49.5Standard Deviation 3.1umol/kg/min
'M' = Whole Body Insulin SensitivityHealthy Controls5.0Inter-Quartile Range 3.7 to 6.6mg/kg/min
'M' = Whole Body Insulin SensitivityPatients With PAD3.4Inter-Quartile Range 2.7 to 4.8mg/kg/min
'M' = Whole Body Insulin SensitivityPAD (Excluding Diabetes)3.4Inter-Quartile Range 2.8 to 4.9mg/kg/min

Participant flow21

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDHealthy Controls11
Overall StudySTARTEDPatients With PAD37
Overall StudySTARTEDPAD (Excluding Patients With Diabetes)28
Overall StudyReceived Atorvastatin and PioglitazoneHealthy Controls3
Overall StudyReceived Atorvastatin and PioglitazonePatients With PAD9
Overall StudyReceived Atorvastatin and PioglitazonePAD (Excluding Patients With Diabetes)7
Overall StudyReceived Atorvastatin and PlaceboHealthy Controls2
Overall StudyReceived Atorvastatin and PlaceboPatients With PAD9
Overall StudyReceived Atorvastatin and PlaceboPAD (Excluding Patients With Diabetes)7
Overall StudyReceived Placebo and PioglitazoneHealthy Controls3

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals12

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityReceived Atorvastatin/Pioglitazone
Total, all-cause mortalityReceived Atorvastatin/Placebo
Total, all-cause mortalityReceived Placebo/Pioglitazone
Total, all-cause mortalityReceived Placebo/Placebo
Total, other adverse eventsReceived Atorvastatin/Pioglitazone019
Total, other adverse eventsReceived Atorvastatin/Placebo018
Total, other adverse eventsReceived Placebo/Pioglitazone020
Total, other adverse eventsReceived Placebo/Placebo019
Total, serious adverse eventsReceived Atorvastatin/Pioglitazone019
Total, serious adverse eventsReceived Atorvastatin/Placebo018

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
25095746DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01HL075771Inflammation and Insulin Resistance in PADCREAGER, MARK ABRIGHAM AND WOMEN'S HOSPITALNATIONAL HEART, LUNG, AND BLOOD INSTITUTE2003 to 2007

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00153166

GET https://conductscience.org/api/trials/v1/NCT00153166/flow?page=2