Insulin Resistance Clinical Trial
Official title:
The Contribution of Inflammation and Insulin Resistance to Intermittent Claudication
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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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