Status:
COMPLETED
Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Insulin Resistance
Atherosclerosis
Eligibility:
All Genders
35-60 years
Brief Summary
People with diabetes are at increased risk for atherosclerosis and have high CVD morbidity and mortality rates. Tools for detecting and quantifying atherosclerotic pro/regression in people with diabet...
Eligibility Criteria
Inclusion
- Inclusion Criteria for HIV+ group:
- confirmed HIV+ status
- 35-60 years old
- stable ART for at least the past 4 mos
- CD4 count \>200 cells/µL
- HIV RNA \<40copies/mL
- fasting glucose=100-126 mg/dL
- 2hr-oGTT glucose=140-200mg/dL
- fasting triglycerides \>150mg/dL
- HDL-cholesterol \<40mg/dL (men), \<50mg/dL (women)
- resting blood pressure\>130/85mmHg
- waist circumference \>102cm(men), \>88cm(women)
- BMI 25-35 kg/m2
- For HIV-negative control group:
- Confirmed HIV negative status
- 35-60 years old
- fasting glucose\<100mg/dL,
- 2hr-oGTT glucose\<140mg/dL
- fasting triglycerides\<150mg/dL
- HDL-cholesterol \>40mg/dL (men), \>50mg/dL(women)
- normal BP (\<130/85mmHg)
- no central adiposity (waist circ.\<102cm(men), \<88cm(women)
- BMI (25-35 kg/m2)
- Exclusion Criteria for both groups:
- history of heart disease, MI, stroke, transient ischemic attack, kidney or liver disease (active hepatitis B or C), dementia
- statins, fibrates, TZDs, antihypertensives, low dose aspirin, or other prescribed/over-the-counter agents with anti-inflammatory properties
- cocaine and methamphetamine users
- serum creatinine \>1.5 mg/dL
- pregnant women
- cognitive impairment that limits ability to provide voluntary informed consent
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00958815
Start Date
March 1 2009
End Date
March 1 2010
Last Update
June 26 2012
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110