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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00153166
Other study ID # 2003P-001501
Secondary ID R01HL075771
Status Completed
Phase Phase 2/Phase 3
First received September 8, 2005
Last updated September 22, 2014
Start date January 2004
Est. completion date December 2011

Study information

Verified date September 2014
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00225940

Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date December 2011
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
atorvastatin and pioglitazone
atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)
atorvastatin/placebo
atorvastatin 80 mg orally once daily and matching placebo orally twice daily
pioglitazone/placebo
pioglitazone 30 mg orally once daily and matching placebo orally once daily
placebo/placebo
placebo orally three times daily

Locations

Country Name City State
United States Brigham & Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower Extremity Skeletal Muscle Glucose Uptake Net calf skeletal muscle glucose uptake determined by Patlak modeling. 60 minutes No
Secondary 'M' = Whole Body Insulin Sensitivity 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. every 5 minutes for 20 minutes No
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