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

Study Overview
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Brief Summary
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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: Comparison of the detection sensitivity of IE outbreaks between 18F-FDG PET/CT performed with the low carbohydrate diet and conventional diet performed 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. Characterization of metabolic changes generated by the low carbohydrate diet using plasma bioassays (blood glucose, insulinemia, free fatty acid concentration, ß-hydroxybutyrate).

Official Title
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Evaluation of a Low-Carbohydrate Diet to Highlight Easily Infective Endocarditis by 18F-FDG PET

Conditions
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Infective Endocarditis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients with certainly infective endocarditis (95%) such Duke and Li criteria Patients with a social protection system No impossibility of performing (18)F-FDG PET (agitated, confused patient, etc) Stable clinically Adaptive antibiotic therapy for at least 8 days No known allergy to making impossible to follow strict carbohydrate diet Exclusion Criteria: Pregnancy, breastfeeding and woman of childbearing age without effective contraception Patients under guardianship or curators. No treatment with corticoids, valproate, carbamazepine, phenytoin, phenobarbital, catecholamines Unbalanced diabetes (fasting capillary blood glucose > 1,8 g/l ou 10 mmol/l) Patients with known hypersensitivity to 18F-FDG or any component of this product

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enrolled patients<br>All enrolled patients will be received a strict low carbohydrate (< 3gr/day of carbohydrate) and 12h fasting before 18F-FDG PET/CT exam and 24h after a 18F-FDG PET/CT preceded by a low carbohydrate diet with 12h fasting | Other: Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT<br>* 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<br>* Other names: 18F-FDG PET/CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious focus 18F-FDG activity measured with SUV (standardized uptake value ) | The contrast will be measured thanks to the ratio SUV (standardized uptake value ) infectious focus and SUV (standardized uptake value ) surrounding tissue | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analysis to detect and locate infective area | each infectious focus will be appreciated by visual reading | 24 hours | 
| SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..) | Measure of 18F-FDG activity on the target organs | 3 days | 
| metabolic biomarker assay: ß-hydroxybutyrate | impact diet on ß-hydroxybutyrate assay result (Measure of β-HydroxybutyrateB from plasma in µmol/L) | one week (on PET standard and on PET with Atkins diet) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infective endocarditis, PET/CT 18F-FDG, Low carbohydrate diet as Atkins diet