Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging

Launched by UNIVERSITY OF PENNSYLVANIA · Feb 12, 2020

Keywords

ClinConnect Summary

This clinical trial is studying different ways to prepare for a specific heart test called an FDG PET/CT scan, which doctors use to check for heart inflammation. Currently, the standard preparation involves following a high-fat, low-carbohydrate diet for 24 hours, then fasting overnight. However, researchers want to find out if there are better methods to reduce the amount of sugar that the heart takes in during the test. Participants in this study will try up to three different preparation methods to see which one works best.

To be eligible for this study, you need to be at least 18 years old and have no history of heart disease, diabetes, or serious liver or kidney problems. This trial is open to both men and women, although women who are pregnant or breastfeeding cannot participate. If you decide to join, you will be informed about the study's purpose and will need to give your written consent. Throughout the study, you can expect to undergo imaging tests and potentially try different diets to help researchers understand how to improve the preparation for the FDG PET/CT scan. Your safety and comfort are a priority, and the study team will ensure that you are suitable for participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients, at least 18 years of age
• • 2. No history of cardiovascular disease, including hypertension, hyperlipidemia, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
• • 3. No history of diabetes mellitus, chronic liver or kidney disease per medical record review and/or self-report.
• • 4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
• Exclusion Criteria:
• • 1. Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test before the first study visit.
• • 2. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
• • 3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.