Insulin ResistanceNCT00958815
Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT
An observational study of Insulin Resistance and Atherosclerosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Atherosclerosis, Cardiovascular Disease
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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
Show all 22Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Keywords
- vascular imaging, diabetes, rupture prone plaques, HIV, treatment experienced
- Medical subject headings
- Insulin Resistance, Atherosclerosis, Cardiovascular Diseases, Acquired Immunodeficiency Syndrome, HIV Infections, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Carotid intima media thickness measures will be compared to carotid 18FDG SUV.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Kevin Yarasheski, Washington University School of Medicine
- Investigators
- Kevin E Yarasheski, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958815
- Sponsor's protocol ID
- 18FDG (completed)
- Other IDs
- DK-020579
- Status last verified
- Jun 2012
- First submitted
- 12 Aug 2009
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Atherosclerotic Plaque Inflammation Imaged Using PDG-PET/CT
- ClinicalTrials.gov ID
- NCT00958815
- Acronym / sponsor ID
- 18FDG (completed)
- Keywords
- vascular imaging, diabetes, rupture prone plaques, HIV, treatment experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Carotid intima media thickness measures will be compared to carotid 18FDG SUV.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- Results publication: PubMed 22726233Yarasheski 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.
- PublicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin E Yarasheski, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Atherosclerosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00958815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.