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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lower Extremity Skeletal Muscle Glucose Uptake | 60 minutes | Net calf skeletal muscle glucose uptake determined by Patlak modeling. |
| Secondary | 'M' = Whole Body Insulin Sensitivity | every 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lower Extremity Skeletal Muscle Glucose Uptake | 60 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/min | MEAN |
| SECONDARY | 'M' = Whole Body Insulin Sensitivity | every 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/min | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lower Extremity Skeletal Muscle Glucose Uptake | Healthy Controls | 62.9 | Standard Deviation 21 | umol/kg/min | |
| Lower Extremity Skeletal Muscle Glucose Uptake | Patients With PAD | 48.6 | Standard Deviation 15 | umol/kg/min | |
| Lower Extremity Skeletal Muscle Glucose Uptake | PAD (Excluding Diabetes) | 49.5 | Standard Deviation 3.1 | umol/kg/min | |
| 'M' = Whole Body Insulin Sensitivity | Healthy Controls | 5.0 | Inter-Quartile Range 3.7 to 6.6 | mg/kg/min | |
| 'M' = Whole Body Insulin Sensitivity | Patients With PAD | 3.4 | Inter-Quartile Range 2.7 to 4.8 | mg/kg/min | |
| 'M' = Whole Body Insulin Sensitivity | PAD (Excluding Diabetes) | 3.4 | Inter-Quartile Range 2.8 to 4.9 | mg/kg/min |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Healthy Controls | 11 | |
| Overall Study | STARTED | Patients With PAD | 37 | |
| Overall Study | STARTED | PAD (Excluding Patients With Diabetes) | 28 | |
| Overall Study | Received Atorvastatin and Pioglitazone | Healthy Controls | 3 | |
| Overall Study | Received Atorvastatin and Pioglitazone | Patients With PAD | 9 | |
| Overall Study | Received Atorvastatin and Pioglitazone | PAD (Excluding Patients With Diabetes) | 7 | |
| Overall Study | Received Atorvastatin and Placebo | Healthy Controls | 2 | |
| Overall Study | Received Atorvastatin and Placebo | Patients With PAD | 9 | |
| Overall Study | Received Atorvastatin and Placebo | PAD (Excluding Patients With Diabetes) | 7 | |
| Overall Study | Received Placebo and Pioglitazone | Healthy Controls | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse 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.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Received Atorvastatin/Pioglitazone | ||
| Total, all-cause mortality | Received Atorvastatin/Placebo | ||
| Total, all-cause mortality | Received Placebo/Pioglitazone | ||
| Total, all-cause mortality | Received Placebo/Placebo | ||
| Total, other adverse events | Received Atorvastatin/Pioglitazone | 0 | 19 |
| Total, other adverse events | Received Atorvastatin/Placebo | 0 | 18 |
| Total, other adverse events | Received Placebo/Pioglitazone | 0 | 20 |
| Total, other adverse events | Received Placebo/Placebo | 0 | 19 |
| Total, serious adverse events | Received Atorvastatin/Pioglitazone | 0 | 19 |
| Total, serious adverse events | Received Atorvastatin/Placebo | 0 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25095746 | DERIVED |
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL075771 | Inflammation and Insulin Resistance in PAD | CREAGER, MARK A | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2003 to 2007 |
Source NIH RePORTER
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.
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