Links Between Inflammation and Cardiometabolic Diseases

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.

Conditions

• Diabetes Mellitus
• Cardiovascular Disease
• Healthy Volunteer
• Inflammation

Interventions

DRUG

13N-amonia

PET/Scan

DRUG

Fludeoxyglucose F18

PET/Scan

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  lead NIH

Principal Investigators

• Michael N Sack, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-02

Primary Completion

2022-08-03

FDA Drug

Yes

Countries

• United States

Study Locations