Scientists probe Inflammation's role in heart disease and diabetes
NCT ID NCT01934660
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 15 times
Summary
This completed study looked at how inflammation might connect heart disease and diabetes. Researchers used PET scans and blood tests to measure inflammation in 150 adults, including healthy volunteers. The goal was to better understand these links, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help identify inflammation as a key factor linking diabetes and heart disease, guiding future treatments.
- What could go wrong
- This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not lead to direct therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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150 people
The number who actually took part.
- Started
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Dec 2013
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy volunteers and participants diagnosed with diabetes or cardiovascular disease will be recruited for this protocol.@@@
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Cardiovascular Disease Eligibility Criteria INCLUSION CRITERIA: * Females and males 18 years of age or older * Diagnosis of clinical CAD (including abnormal EKG with a prior infarction pattern, abnormal echo consistent with a wall motion abnormality or a referral note from cardiologist with diagnosis of CAD) * CAD that is currently stable (defined by no change in medications for blood pressure, angina or diuretic therapy or in no new CV symptoms over the past month in a patient who has had a primary cardiac event or an abnormal EKG with confirmed wall motion abnormality) * CAD which may be associated with chronic stable angina (defined by a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back, or arm by a physician). * CAD that is found on CCTA which may be subclinical EXCLUSION CRITERIA: * Pregnant women or lactating women. * For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation. * For optional MRI, inability to participate due to metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan * Any solid organ or liquid tumor within the past five years, with the exception of nonmelanomatous skin cancer, * Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP) * A BMI \>40 kg/m(2) due to PET MRI restrictions * Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate \< 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI. Diabetes Mellitus Eligibility Criteria INCLUSION CRITERIA: * Females and males 18 years of age or older * Diagnosis of type 2 diabetes mellitus (DM), currently stable as defined by no change in antidiabetic medications over the past month and fasting glucose \<200 EXCLUSION CRITERIA: * Pregnant women and or lactating women. * For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation. * For optional MRI, inability to participate due to metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan * Any solid organ or liquid tumor within the past five years, with the exception of nonmelanomatous skin cancer, * Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP) * A BMI \>40 kg/m(2) due to PET MRI restrictions * Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate \< 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI. * Subjects with second -or third-degree AV block or sinus node dysfunction will not receive the 13N-ammonia PET/CT imaging unless these patients have a functioning artificial pacemaker. * Subjects with any signs or symptoms of acute coronary syndrome, including vasoreactive hypertension with blood pressure exceeding 180/100, any concerning ST segment changes on ECG, or acute chest pain, will not receive the 13N-ammonia PET/CT imaging. Healthy Volunteers: INCLUSION CRITERIA: -Females and males 18 years of age or older without any clinical diagnosis of a chronic health condition that is knownto accelerate vascular disease beyond traditional risk factors including lung disease or active infection EXCLUSION CRITERIA: * For imaging studies, pregnant women * For imaging studies, lactating women * For optional MRI, inability to participate due to in optional MRI metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan * Any solid organ or liquid tumor within the past five years, with the exception of non melanomatous skin cancer, * Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP) * Clinical diagnosis of diabetes or cardiovascular disease * Fasting glucose \>125, * LDL\>200, * LFT s 3 times normal limit, * eGFR\<60, * Subjects with severe renal excretory dysfunction will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI. * A BMI \>40 kg/m(2) due to PET MRI restrictions.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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