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

NCT03465098 | Completed DMC

• 1 other identifier: N°IDRCB: 2017-A01104-49
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Keywords

Infective endocarditis; PET/CT 18F-FDG; Low carbohydrate diet as Atkins diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual analysis to detect and locate infective area

  24 hours

• SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..)

  3 days

• metabolic biomarker assay: ß-hydroxybutyrate

  one week (on PET standard and on PET with Atkins diet)

Study Arms (1)

enrolled patients

EXPERIMENTAL

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

Interventions

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

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

Also known as: 18F-FDG PET/CT

enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Chru Nancy Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Elodie CHEVALIER, MD

  Nuclear medicine department, CHRU NANCY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: March 14, 2018
• Study Start: March 19, 2018
• Primary Completion: December 2, 2020
• Study Completion: August 3, 2021
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)