NCT01934660

Links Between Inflammation and Cardiometabolic Diseases

Completed Last updated 14 April 2026

What this trial tests

trial testing 13N-amonia in Diabetes Mellitus in 150 participants. Completed.

Timeline

2 December 2013

Primary endpoint
3 August 2022

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	2 December 2013
Primary completion	3 August 2022
Sites	1 location across United States

Drugs / interventions tested

• 13N-amonia
• Fludeoxyglucose F18 — full drug profile →

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →
• Healthy Volunteer — all drugs for Healthy Volunteer →
• Inflammation — all drugs for Inflammation →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 100, any sex, with Diabetes Mellitus or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Boosting NAD preferentially blunts Th17 inflammation via arginine biosynthesis and redox control in healthy and psoriasis subjects.
   Han K, Singh K, Meadows AM, Sharma R, et al · · 2023 · cited 23× · PMID 37586364 · DOI 10.1016/j.xcrm.2023.101157
2. PET/CT-Based Characterization of 18F-FDG Uptake in Various Tissues Reveals Novel Potential Contributions to Coronary Artery Disease in Psoriatic Arthritis.
   Schwartz DM, Parel P, Li H, Sorokin AV, et al · · 2022 · cited 15× · PMID 35720288 · DOI 10.3389/fimmu.2022.909760
3. Vascular inflammation in psoriasis localizes to the arterial wall using a novel imaging technique.
   Dave J, Ahlman MA, Lockshin BN, Bluemke DA, et al · · 2014 · cited 10× · PMID 24641984 · DOI 10.1016/j.jaad.2013.12.043
4. Nanotomography of lesional skin using electron microscopy reveals cytosolic release of nuclear DNA in psoriasis.
   Lindberg E, Baumer Y, Stempinski ES, Rodante JA, et al · · 2021 · cited 3× · PMID 33598517 · DOI 10.1016/j.jdcr.2020.12.024
5. Circulating Oxidized mtDNA is Associated Broadly with Cardiovascular Disease in a Longitudinal Cohort Study of Psoriasis.
   Lateef SS, Ward GA, Li H, Pantoja C, et al · · 2024 · cited 2× · PMID 38162017 · DOI 10.1016/j.xjidi.2023.100243
6. Improvement of liver metabolic activity in people with advanced HIV after antiretroviral therapy initiation.
   Patel R, Manion MM, Laidlaw E, Wakim P, et al · · 2022 · cited 2× · PMID 35730393 · DOI 10.1097/qad.0000000000003302
7. Serum Beta-Defensin-2 is a biomarker for psoriasis but not subclinical atherosclerosis: Role of IL17a, PI-3 kinase and Rac1.
   Pantoja CJ, Li H, Rodante J, Keel A, et al · · 2024 · cited 1× · PMID 38646149 · DOI 10.1002/jvc2.278
8. HDL-associated vitamin D binding protein levels are inversely associated with necrotic plaque burden in psoriasis.
   Playford MP, Li H, Dey AK, Florida EM, et al · · 2025 · PMID 39811778 · DOI 10.1016/j.athplu.2024.12.002