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Evaluation of a Metabolic Preparation by a Low-carbohydrate Diet as Atkins-diet to Help in Detecting Infective Endocarditis by 18F-FDG PET

NCT03465098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-02-09

No results posted yet for this study

Summary

Infectious endocarditis (IE) is a pathology where the mortality rate of between 20 and 25%, but a higher morbidity since 50% of the patients are treated by a valvular surgical procedure. The diagnosis of IE is often difficult and therefore too late. In 2015, the European Society of Cardiology recommendations published by the integrate Positron Emission Tomography with Computed Tomography (PET/CT) with 18F-Fluorodeoxyglucose (18F-FDG) in the diagnostic management of IE.

However, during conventional examinations, with 12 hours fasting and low carb dieting, myocardial uptake of 18F-FDG may be intense and interfere with results.

The purpose of this study is to assess a strict low carbohydrate diet as Atkins (\<3gram/day of carbohydrate) diet to facilitate the infective endocarditis diagnosis by 18F-FDG PET/CT Primary objective is to assess a strict low carbohydrate diet during 12h and 12h fasting for enhancing the contrast between infect area and surrounding structures and improve the detectability of infective endocarditis by PET/CT

Secondary objectives:

1. Comparison of the detection sensitivity of IE outbreaks between 18F-FDG PET/CT performed with the low carbohydrate diet and conventional diet performed
2. To assess the strict low carbohydrate diet effects on the uptake 18F-FDG distribution , particularly in the myocardium, circulating blood, skeletal muscles, brain and liver.
3. Characterization of metabolic changes generated by the low carbohydrate diet using plasma bioassays (blood glucose, insulinemia, free fatty acid concentration, ß-hydroxybutyrate).

Conditions

  • Infective Endocarditis

Interventions

OTHER

Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT

The patients will receive 2 PET/CT , first exam with standard diet preceded by 12h fasting and second exam preceded by 3 meals strict low diet and 12h fasting

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Elodie CHEVALIER, MD · Nuclear medicine department, CHRU NANCY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2020-12-02
Completion
2021-08-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03465098 on ClinicalTrials.gov