Expired Study
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Boston, Massachusetts 02115


Purpose:

This trial will test the hypothesis that inflammation and insulin resistance contribute to reduced walking distance in subjects with intermittent claudication by impairing vascular reactivity and skeletal muscle metabolic function.


Study summary:

People with peripheral arterial disease (PAD), an important clinical manifestation of atherosclerosis, often suffer symptoms of intermittent claudication that impair their walking ability and adversely affect their quality of life. People with PAD are also at increased risk for adverse cardiovascular events, including myocardial infarction, stroke and death. Unfortunately, medical therapies directed to the functional and limb-threatening manifestations are limited. Little attention has been paid to the biologic processes that cause PAD, and to atherogenic mechanisms that may preferentially affect the peripheral circulation. Vascular inflammation and insulin resistance are two important and interdependent conditions that are associated with atherosclerosis. Subjects in this trial (160 non-diabetic adults with stable intermittent claudication) will be randomized in a placebo-controlled, parallel design manner, to atorvastatin 80 mg orally daily (to reduce inflammation) and pioglitazone 45 mg orally once daily (to improve insulin sensitivity). Forty healthy adult subjects, age and gender-matched to a subset of the study group, will be enrolled to serve as a control population. Primary and secondary study endpoints include: treadmill walking time, endothelium-dependent vasodilation, and insulin-mediated skeletal muscle glucose uptake.


Criteria:

Inclusion Criteria: - symptomatic intermittent claudication for >= 6 months - resting ankle/brachial index (ABI) <=0.90 - maximal treadmill walking time between 1-20 minutes - >= 20% decrease in ABI post treadmill exercise - 4 week statin wash-out prior to initial study testing (if applicable) Exclusion Criteria: - myocardial infarction or coronary artery bypass surgery within past 6 months - lower extremity revascularization (surgical or percutaneous) within past 6 months - transient ischemic attack or ischemic stroke within past 6 months - pregnancy - uncontrolled hypertension (systolic pressure > 180mmHg and/or diastolic pressure > 100mmHg - serum creatinine >2.5 - hepatic transaminases (AST, ALT) > 3x upper limit of normal (ULN) - creatine kinase > 5x ULN - known hypersensitivity to HMG-CoA reductase inhibitors - insulin dependent Type 2 diabetes - current treatment with thiazolidinedione


NCT ID:

NCT00153166


Primary Contact:

Principal Investigator
Mark Creager, M.D.
Brigham and Women's Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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