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| ID | Type | Description | Link |
|---|---|---|---|
| 13-H-0194 |
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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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Healthy volunteers |
| |
| Group 2 | Subjects diagnosed with diabetes |
| |
| Group 3 | Subjects diagnosed cardiovascular disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13N-amonia | Drug | PET/Scan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Diabetes Mellitus Eligibility Criteria
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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:
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Healthy volunteers and participants diagnosed with diabetes or cardiovascular disease will be recruited for this protocol.@@@
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany M Powell-Wiley, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37586364 | Derived | 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. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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| Fludeoxyglucose F18 |
| Drug |
PET/Scan |
|
| 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 | 1 day to 10 years |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |