Status:
COMPLETED
Free Fatty Acids and Vascular Function in Subjects With Diabetes
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal muscle glucose metabolis...
Detailed Description
During the past two decades, there has been a steady increase in the incidence of diabetes mellitus, such that nearly 17 million people are now afflicted. The vast majority of these have type 2 diabet...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus (as defined by the National Diabetes Data Group)
- normal cardiovascular exam
- non smoker (for 1 year prior to entry)
- Healthy volunteers
- no known medical problems
- normal cardiovascular exam
- fasting glucose \< 110 mg/dL
- non-smoker (for 1 year prior to entry)
Exclusion
- Type 2 Diabetics
- untreated hypertension (\>140/90 mmHg)
- untreated hypercholesterolemia (LDL \> 75th percentile for age)
- cigarette smoking within 1 year
- neuropathy requiring medication
- nephropathy (\> 300mg/24 hour urinary albumin, or serum creatinine \> 1.4 mg/dL
- abnormal cardiovascular exam
- treatment with thiazolidinedione within 1 year
- post-menopausal women taking hormone replacement therapy
- (Note: subjects taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) must stop these medications for 2 weeks prior to taking study drug. If blood pressure rises to \>140/90, subjects will be prescribed an alternative medication or be withdrawn from the study.
- Healthy Volunteers
- abnormal cardiovascular exam
- use of prescription medications
- fasting glucose \> 110mg/dL
- cigarette smoking within 1 year
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00153179
Start Date
September 1 2005
End Date
March 1 2013
Last Update
September 25 2018
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115