Links Between Inflammation and Cardiometabolic Diseases

NCT01934660 | Completed FDA Drug

• 2 other identifiers: 13019413-H-0194
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiovascular Disease; Diabetes Mellitus; Inflammation; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

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.

  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

  1 day to 10 years

Study Arms (3)

Group 1

Healthy volunteers

Drug: 13N-amonia; Drug: Fludeoxyglucose F18

Group 2

Subjects diagnosed with diabetes

Drug: 13N-amonia; Drug: Fludeoxyglucose F18

Group 3

Subjects diagnosed cardiovascular disease

Drug: 13N-amonia; Drug: Fludeoxyglucose F18

Interventions

13N-amonia DRUG

PET/Scan

Group 1; Group 2; Group 3

Fludeoxyglucose F18 DRUG

PET/Scan

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and participants diagnosed with diabetes or cardiovascular disease will be recruited for this protocol.@@@

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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
• 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)

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 37586364 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Inflammation

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Michael N Sack, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 4, 2013
• Study Start: December 2, 2013
• Primary Completion: August 3, 2022
• Last Updated: April 20, 2026

Record last verified: 2025-09-22

Locations

US (1)