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CompletedNCT00958815Updated Jun 26, 2012

Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT

An observational study in Insulin Resistance, Atherosclerosis and Cardiovascular Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-26.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
14
Ages
35 Years to 60 Years
Sex
All
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Study 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 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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Conditions studied

  • Insulin Resistance
  • Atherosclerosis
  • Cardiovascular Disease
  • HIV/AIDS
  • HIV Infections

Keywords

  • vascular imaging
  • diabetes
  • rupture prone plaques
  • HIV
  • treatment experienced
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 14 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects will be recruited through the AIDS Clinical Trials Unit (ACTU), Washington University Infectious Diseases Clinics, primary care physicians in the community who refer patients to these clinics and Volunteers for Health (VFH).

Inclusion criteria

  • 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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
14 participants (actual)

Groups and cohorts

  • HIV-seronegative with no CVD risk factors

    Healthy, 35-60 yr old HIV-seronegative men and women with no CVD risk factors (normal fasting glucose tolerance, normal fasting lipid/lipoprotein levels, normotensive, waist circumference \<102cm (men) and \<88cm (women).

  • HIV+ with CVD risk factors

    35-60 yr old HIV-infected men and women with insulin resistance, dyslipidemia, hypertension, and central adiposity.

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What researchers measure

Primary outcomes

  1. 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

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

    Time frame: Baseline

07

Study locations

1 site
  • Washington University School of Medicine
    St.Louis, Missouri 63110, United States
08

References and documents

Publications

  • Yarasheski KE, Laciny E, Overton ET, Reeds DN, Harrod M, Baldwin S, Davila-Roman VG. 18FDG PET-CT imaging detects arterial inflammation and early atherosclerosis in HIV-infected adults with cardiovascular disease risk factors. J Inflamm (Lond). 2012 Jun 22;9(1):26. doi: 10.1186/1476-9255-9-26. PubMed 22726233 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00958815
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Kevin Yarasheski (Professor of Medicine, Cell Biology & Physiology, Physical Therapy, Washington University School of Medicine) — Principal investigator
First posted
Aug 13, 2009
Start date
Mar 2009
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Jun 26, 2012

Study contacts

Kevin E Yarasheski, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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