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CompletedNCT03465098TEPEIRUpdated Feb 9, 2024

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

An interventional study of Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT in Infective Endocarditis, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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).
02

Conditions studied

  • Infective Endocarditis

Keywords

  • Infective endocarditis
  • PET/CT 18F-FDG
  • Low carbohydrate diet as Atkins diet
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    enrolled patients

    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

  • OtherStrict 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

    Also known as: 18F-FDG PET/CT

05

What researchers measure

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

    Time frame: 24 hours

Secondary outcomes

  1. Visual analysis to detect and locate infective area

    each infectious focus will be appreciated by visual reading

    Time frame: 24 hours

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

    Measure of 18F-FDG activity on the target organs

    Time frame: 3 days

  3. metabolic biomarker assay: ß-hydroxybutyrate

    impact diet on ß-hydroxybutyrate assay result (Measure of β-HydroxybutyrateB from plasma in µmol/L)

    Time frame: one week (on PET standard and on PET with Atkins diet)

06

Study locations

1 site
  • Chru Nancy Brabois
    Vandœuvre-lès-Nancy, 54511, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03465098
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Elodie CHEVALIER (Principal investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Mar 14, 2018
Start date
Mar 19, 2018
Primary completion
Dec 2, 2020
Completion
Aug 3, 2021
Last update
Feb 9, 2024

Study contacts

Elodie CHEVALIER, MD
principal investigator · Nuclear medicine department, CHRU NANCY

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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