Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00153166
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2005-09-08
Brief Title:
ARREST PAD Peripheral Arterial Disease
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
The Contribution of Inflammation and Insulin Resistance to Intermittent Claudication
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 adults with stable intermittent claudication who are not taking insulin or insulin-sensitizing medications such as thiazolidinediones 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
Vascular inflammation and insulin resistance are two important and interdependent conditions that are associated with atherosclerosis Subjects in this trial 160 adults with stable intermittent claudication who are not taking insulin or insulin-sensitizing medications such as thiazolidinediones 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL075771 | NIH | None | httpsreporternihgovquickSearchR01HL075771 |