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

Infective Endocarditis Clinical Trial

— TEPEIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465098
• Other study ID #: N°IDRCB: 2017-A01104-49
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: August 3, 2021

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 3, 2021
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

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

Locations

Country	Name	City	State
France	Chru Nancy Brabois	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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