Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT

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 diabetes and other CVD risk factors lack sensitivity and specificity for molecular level events that occur during the early stages of atherogenesis. Inflammatory macrophage infiltration in the vessel endothelium is an early, molecular level proatherogenic event. Activated macrophages consume glucose at a high rate. Novel in vivo radiotracer PET/CT techniques have been developed to detect, image and quantify molecular level events like macrophage inflammation and glucose utilization (18FDG) in human vessels. We propose to develop and test this novel technique in the Center for Clinical Imaging Research (CCIR) at WUMS. We propose that HIV-infected people with significant CVD risk profiles are a suitable, unique human model for testing these novel imaging techniques. HIV-infected people taking anti-HIV medications develop insulin resistance, T2DM, dyslipidemia, central adiposity, and hypertension. HIV replicates in macrophages and represents a chronic proinflammatory condition. Recent data indicate that HIV+ CVD risk have greater risk for atherosclerosis and MI than HIV-negative people. To test feasibility, we hypothesize that: a.18FDG-PET/CT imaging will detect more macrophage glucose uptake and inflammation in the carotid and aorta arteries of HIV-infected people with CVD risk than in HIV-negative controls; b. radiotracer PET/CT measures of proatherogenic processes will correlate with carotid intima media thickness; a standard measure of carotid atherosclerotic burden. We propose to obtain pilot data that shows feasibility for a novel analytical approach that will expand capabilities for researchers interested in studying the links between diabetes, inflammation, and CVD in humans.

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Key information

Conditions

Insulin Resistance Acquired Immunodeficiency Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Blood-Borne Infections Cardiovascular Disease Cardiovascular Diseases Communicable Diseases Diabetes Mellitus Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections HIV/AIDS Hyperinsulinism Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Standard uptake values (SUV) for 18Fluoro-deoxyglucose in the carotid vessels and aorta of HIV-infected people with cardiovascular disease risk factors and compared to the same in HIV-seronegative people with no cardiovascular disease risk factors.

Time frame: Baseline

Secondary outcomes

Carotid intima media thickness measures will be compared to carotid 18FDG SUV.

Time frame: Baseline

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 13, 2009
Registry last updated: Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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