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NCT Number: NCT04275453

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

The purpose of this study is to test different methods of preparation that can be used prior to a test called an FDG PET/CT scan. FDG PET/CT scans are routinely done for evaluation of heart inflammation. Standard preparation for the scan includes a ketogenic (high fat and low carbohydrate) diet for 24 hours and overnight fasting to help suppress the amount of sugar taken up in the heart muscle. However, Investigator still do not know if this preparation is the most effective method. So the Investigator, want to investigate alternative methods for decreasing the amount of sugar uptake seen in the heart during FDG PET/CT scan, thus, investigator will have participants try up to 3 different methods of preparation prior to the FDG PET/CT scans to see which type of preparation works the best.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, at least 18 years of age
  • No history of cardiovascular disease, including hypertension, hyperlipidemia, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
  • No history of diabetes mellitus, chronic liver or kidney disease per medical record review and/or self-report.
  • 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

  • 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.
  • Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
  • 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.

Treatment and study plan

FDG

Drug

FDG is a FDA approved radiotracer which each subject will have 3 positron emission tomography/computed tomography (PET/CT) scan performed.

Ketone drink

Dietary Supplement

Subjects will undergo FDG PET/CT after 1 dose of ketone drink administration after 12 hours of fasting prior to FDG injection. The dosing of ketone drink administration (approximately 65 mL) will be weight based (714 mg/kg), which is crucial to replicating ketone levels between participants

Ketogenetic Diet

Other

Subjects needs to be on Ketogenetic diet

Primary outcomes

  1. Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT

    Time frame: 3 years

    Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT. Images will be qualitative and semi-quantitatively assessed. The entire right and left ventricular walls will be contoured in a dedicated nuclear medicine workstation (MIM Software) to create volume of interest s(VOI) and derive the maximum and mean standardized uptake value (SUV) and total glycolytic activity (TGA), all measures of glucose utilization. Blood pool activity within the left ventricular cavity will be used as reference. Complete myocardial suppression will be defined as FDG activity (by any measure) in the left ventricular wall lower than blood pool activity in the ventricular cavity.

Secondary outcomes

  1. The optimal duration of ketosis to produce myocardial suppression by looking at the FDG uptake using PET/CT by comparing the data out of 1 day keto diet Arm versus 3 days Keto diet Arm

    Time frame: 3 years

    The optimal duration of ketosis to produce myocardial suppression by looking at the FDG uptake using PET/CT by comparing the data out of 1 day keto diet Arm versus 3 days Keto diet Arm.

  2. Understanding the relationship between serum β-hydroxybutyrate (BHB) levels and myocardial glucose by looking at the FDG uptake using PET/CT by comparing the data out of keto diet Arm versus Ketone supplement Arm.

    Time frame: 3 years

    Understanding the relationship between serum β-hydroxybutyrate (BHB) levels and myocardial glucose by looking at the FDG uptake using PET/CT by comparing the data out of keto diet Arm versus Ketone supplement Arm by measuring serum levels of BHB, free fatty acid, acylcarnitine, glucose, and insulin at each FDG PET/CT visit. Approximately 15 mLs of blood will be drawn and used to measure B-Hydroxybutyrate (BHB), acylcarnitines, insulin, glucose and free fatty acid and other targeted metabolomics

  3. comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement

    Time frame: 3 years

    comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement. Transthoracic Echocardiogram: Ultrasound will be used to create an image of the internal parts of the heart. This test is being done to assess any changes in cardiac function with the ketone drink. We will perform echocardiography before and approximately 30 minutes after the drink.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 19, 2020
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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