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NCT04275453 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Healthy, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04275453: Recruiting Phase 1 study of Healthy, sponsored by University of Pennsylvania.
NCT04275453 is a Phase 1 study of Healthy that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04275453, a Phase 1 study of Healthy, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG FDG
- DIETARY_SUPPLEMENT Ketone Drink
- OTHER Ketogenetic Diet
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-01-05 |
| Est. Completion | 2023-01-05 |
| Phase | Phase 1 |
What NCT04275453 shows while recruiting
NCT04275453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which FDG is the first listed.
NCT04275453 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04275453 about?
NCT04275453 is a clinical study titled "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 ...
What is the current status of trial NCT04275453?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-01-05. Estimated completion is 2023-01-05.
What conditions does trial NCT04275453 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04275453?
The interventions under investigation include: FDG (DRUG), Ketone Drink (DIETARY_SUPPLEMENT), Ketogenetic Diet (OTHER).
Who is sponsoring clinical trial NCT04275453?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04275453 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04275453's enrollment target sits among peer trials
20 861st of 1090 higher than 194 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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