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临床试验/NCT03465098
NCT03465098已完成不适用

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

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Infectious focus 18F-FDG activity measured with SUV (standardized uptake value )

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

干预措施: Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT (Other)

结局指标

主要结局

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

时间窗: 24 hours

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

次要结局

  • metabolic biomarker assay: ß-hydroxybutyrate(one week (on PET standard and on PET with Atkins diet))
  • SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..)(3 days)
  • Visual analysis to detect and locate infective area(24 hours)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elodie CHEVALIER

Principal investigator

Central Hospital, Nancy, France

研究点 (1)

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