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NCT Number: NCT03465098

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chru Nancy Brabois

Vandœuvre-lès-Nancy, 54511, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: 18F-FDG PET/CT

Primary outcomes

  1. Infectious focus 18F-FDG activity measured with SUV (standardized uptake value )

    Time frame: 24 hours

    The contrast will be measured thanks to the ratio SUV (standardized uptake value ) infectious focus and SUV (standardized uptake value ) surrounding tissue

Secondary outcomes

  1. Visual analysis to detect and locate infective area

    Time frame: 24 hours

    each infectious focus will be appreciated by visual reading

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

    Time frame: 3 days

    Measure of 18F-FDG activity on the target organs

  3. metabolic biomarker assay: ß-hydroxybutyrate

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

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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: TEPEIR

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 14, 2018
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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