Diabetes MellitusNCT01934660
Links Between Inflammation and Cardiometabolic Diseases
An observational study of Diabetes Mellitus and Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Cardiometabolic diseases are a combination of medical disorders that, when they occur together, increase the risk of heart disease and diabetes. Researchers want to learn if there is a relationship between these diseases and inflammation (redness, swelling, and pain). Inflammation affects the entire body. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Disease, Healthy Volunteer
- What is being tested?
- 13N-amonia and Fludeoxyglucose F18
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2013to 3 Aug 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy volunteers and participants diagnosed with diabetes or cardiovascular disease will be recruited for this protocol.@@@
Who may be able to join
- 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
- 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
- -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
Who cannot join
- 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
Show all 30Show fewer
- 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
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Inflammatory Characterization of Known or Possible Cardiovascular Diseases
Background:
- Cardiometabolic diseases are a combination of medical disorders that, when they occur together, increase the risk of heart disease and diabetes. Researchers want to learn if there is a relationship between these diseases and inflammation (redness, swelling, and pain). Inflammation affects the entire body. Researchers will study this relationship in people with heart disease and diabetes, and compare it to healthy people.
Read more
Objectives:
- To learn if there are links between inflammation and cardiometabolic diseases.
Eligibility:
- Adults 18 years of age or older with heart disease or diabetes.
- Healthy volunteers 18 years of age or older.
Design:
- Participants will have up to six study visits. There will be first visit, then an optional visit 12 months after the first visit.
- At the study visits they will have:
- Blood taken with a needle in their arm.
- An electrocardiogram. Small patches are stuck to the chest and limbs. A machine measures electrical signals of the heart.
- Completed a number of questionnaires.
- A body scan called an FDG PET/CT. A substance will be injected through a tube in their arm. They will lie on a special bed that will move in and out of the PET/CT scanner. The PET/CT scanner will take pictures of the body. The scan will last up to 30 minutes.
- Some participants will have other body scans ( FDG PET/MRI). The procedures are similar to the FDG PET/CT scan. These other scans will last about 30 minutes total.
- Some participants will also have a CT scan of their heart. A substance will be injected through a tube in their arm. They will lie on a table in a large, donut-shaped machine. An X-ray tube will move around their body, taking many pictures. This procedure can last up to 2 hours.
- Some participants will have tests that measures blood pressure and how the blood moves through the body.
- Some participants will have small samples of skin and fat tissue taken.
Read the detailed description
Over the past two decades, the number of subjects with cardiometabolic diseases (CMD) such as atherosclerotic cardiovascular disease (CVD), dyslipidemia, insulin resistance and diabetes have been rising. Characterizing these disease states reveals that inflammation is a common feature of CMD; however, mechanistic links between inflammation and these disease states in humans remain poorly understood. In this protocol, we aim to characterize inflammation within the blood vessels, blood, fat and skin in diabetes and coronary artery disease compared to those without disease. We hypothesize that diabetes and coronary disease will be systemic inflammatory states and will provide an important frame of reference for parameters found on novel imaging techniques in another ongoing protocol trying to understand how skin inflammation affects risk for CMD and CVD (13-H-0065).
- Being tested
- 13N-amonia, Fludeoxyglucose F18
- Keywords
- Cardiovascular Disease, Diabetes Mellitus, Inflammation, Natural History
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13N-amoniaDrug
PET/Scan
Fludeoxyglucose F18Drug
PET/Scan
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Healthy volunteers Receives: Drug: 13N-amonia; Drug: Fludeoxyglucose F18 | |
| Group 2 | Subjects diagnosed with diabetes Receives: Drug: 13N-amonia; Drug: Fludeoxyglucose F18 | |
| Group 3 | Subjects diagnosed cardiovascular disease Receives: Drug: 13N-amonia; Drug: Fludeoxyglucose F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
Measured: 1 day to 10 years
Secondary outcomes (2)
Our secondary outcomes are mean aortic wall thickness at the most diseased segment on FDG PET/CT and vessel wall area on MRI at the most diseased segment, and we will perform analyses using a model including the same variables as above.
Mean Aortic Wall Thickness at the most diseased segment (measured by MRI at FDG PET MRI) --Vessel Wall Area at the most diseased segment (measured by MRI at FDG PET MRI)
Measured: 1 day to 10 years
As a tertiary analysis, we will add novel biomarkers to the above models including HDL efflux, HOMA-IR and inflammatory mediators to understand the association of each biomarker on vascular disease markers
to understand the association of each biomarker on vascular disease markers
Measured: 1 day to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study start2 Dec 2013
- Primary completion3 Aug 2022
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tiffany M Powell-Wiley, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934660
- Sponsor's protocol ID
- 130194
- Other IDs
- 13-H-0194
- Status last verified
- 14 Aug 2026
- First submitted
- 28 Aug 2013
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Han K, Singh K, Meadows AM, Sharma R, Hassanzadeh S, Wu J, Goss-Holmes H, Huffstutler RD, Teague HL, Mehta NN, Griffin JL, Tian R, Traba J, Sack MN. Boosting NAD preferentially blunts Th17 inflammation via arginine biosynthesis and redox control in healthy and psoriasis subjects. Cell Rep Med. 2023 Sep 19;4(9):101157. doi: 10.1016/j.xcrm.2023.101157. Epub 2023 Aug 15.
PubMed 37586364
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Characterization of Known or Possible Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT01934660
- Acronym / sponsor ID
- 130194
- Keywords
- Cardiovascular Disease, Diabetes Mellitus, Inflammation, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 2 Dec 2013 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- First posted
- 4 Sep 2013 (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.
Background:
- Cardiometabolic diseases are a combination of medical disorders that, when they occur together, increase the risk of heart disease and diabetes. Researchers want to learn if there is a relationship between these diseases and inflammation (redness, swelling, and pain). Inflammation affects the entire body. Researchers will study this relationship in people with heart disease and diabetes, and compare it to healthy people.
Objectives:
- To learn if there are links between inflammation and cardiometabolic diseases.
Eligibility:
- Adults 18 years of age or older with heart disease or diabetes.
- Healthy volunteers 18 years of age or older.
Design:
- Participants will have up to six study visits. There will be first visit, then an optional visit 12 months after the first visit.
- At the study visits they will have:
- Blood taken with a needle in their arm.
- An electrocardiogram. Small patches are stuck to the chest and limbs. A machine measures electrical signals of the heart.
- Completed a number of questionnaires.
- A body scan called an FDG PET/CT. A substance will be injected through a tube in their arm. They will lie on a special bed that will move in and out of the PET/CT scanner. The PET/CT scanner will take pictures of the body. The scan will last up to 30 minutes.
- Some participants will have other body scans ( FDG PET/MRI). The procedures are similar to the FDG PET/CT scan. These other scans will last about 30 minutes total.
- Some participants will also have a CT scan of their heart. A substance will be injected through a tube in their arm. They will lie on a table in a large, donut-shaped machine. An X-ray tube will move around their body, taking many pictures. This procedure can last up to 2 hours.
- Some participants will have tests that measures blood pressure and how the blood moves through the body.
- Some participants will have small samples of skin and fat tissue taken.
Detailed description
Over the past two decades, the number of subjects with cardiometabolic diseases (CMD) such as atherosclerotic cardiovascular disease (CVD), dyslipidemia, insulin resistance and diabetes have been rising. Characterizing these disease states reveals that inflammation is a common feature of CMD; however, mechanistic links between inflammation and these disease states in humans remain poorly understood. In this protocol, we aim to characterize inflammation within the blood vessels, blood, fat and skin in diabetes and coronary artery disease compared to those without disease. We hypothesize that diabetes and coronary disease will be systemic inflammatory states and will provide an important frame of reference for parameters found on novel imaging techniques in another ongoing protocol trying to understand how skin inflammation affects risk for CMD and CVD (13-H-0065).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: 13N-amonia, Drug: Fludeoxyglucose F18Healthy volunteers |
| Group 2 | – | Drug: 13N-amonia, Drug: Fludeoxyglucose F18Subjects diagnosed with diabetes |
| Group 3 | – | Drug: 13N-amonia, Drug: Fludeoxyglucose F18Subjects diagnosed cardiovascular disease |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and participants diagnosed with diabetes or cardiovascular disease will be recruited for this protocol.@@@
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13N-amoniaPET/Scan | Drug | Group 1, Group 2, Group 3 |
| Fludeoxyglucose F18PET/Scan | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
Time frame: 1 day to 10 years
vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
2 secondary outcomes
Our secondary outcomes are mean aortic wall thickness at the most diseased segment on FDG PET/CT and vessel wall area on MRI at the most diseased segment, and we will perform analyses using a model including the same variables as above.
Time frame: 1 day to 10 years
As a tertiary analysis, we will add novel biomarkers to the above models including HDL efflux, HOMA-IR and inflammatory mediators to understand the association of each biomarker on vascular disease markers
Time frame: 1 day to 10 years
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 18 Aug 2026.
- Derived from this study: PubMed 37586364Han K, Singh K, Meadows AM, Sharma R, Hassanzadeh S, Wu J, Goss-Holmes H, Huffstutler RD, Teague HL, Mehta NN, Griffin JL, Tian R, Traba J, Sack MN. Boosting NAD preferentially blunts Th17 inflammation via arginine biosynthesis and redox control in healthy and psoriasis subjects. Cell Rep Med. 2023 Sep 19;4(9):101157. doi: 10.1016/j.xcrm.2023.101157. Epub 2023 Aug 15.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
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.
Tiffany M Powell-Wiley, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 Diabetes Mellitus and Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) 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 8 inclusion and 30 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 18 Aug 2026. 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?
Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG (time frame: 1 day to 10 years). 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 NCT01934660, 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 18 Aug 2026.