Links Between Inflammation and Cardiometabolic Diseases
Condition: Diabetes Mellitus; Cardiovascular Disease; Healthy Volunteer; Inflammation
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Inflammation
Study type: Observational

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. 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).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers and participants diagnosed with diabetes or cardiovascular disease will
        be recruited for this protocol.@@@
      
Keywords: Cardiovascular Disease; Diabetes Mellitus; Inflammation; Natural History