Evaluation of a Metabolic Preparation by a Low-carbohydrate Diet as Atkins-diet to Help in Detecting Infective Endocarditis by 18F-FDG PET (TEPEIR)
Primary Purpose
Infective Endocarditis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Infective Endocarditis focused on measuring Infective endocarditis, PET/CT 18F-FDG, Low carbohydrate diet as Atkins diet
Eligibility Criteria
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
Sites / Locations
- Chru Nancy Brabois
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
enrolled patients
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual analysis to detect and locate infective area
each infectious focus will be appreciated by visual reading
SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..)
Measure of 18F-FDG activity on the target organs
metabolic biomarker assay: ß-hydroxybutyrate
impact diet on ß-hydroxybutyrate assay result (Measure of β-HydroxybutyrateB from plasma in µmol/L)
Full Information
NCT ID
NCT03465098
First Posted
November 17, 2017
Last Updated
August 3, 2021
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03465098
Brief Title
Evaluation of a Metabolic Preparation by a Low-carbohydrate Diet as Atkins-diet to Help in Detecting Infective Endocarditis by 18F-FDG PET
Acronym
TEPEIR
Official Title
Evaluation of a Low-Carbohydrate Diet to Highlight Easily Infective Endocarditis by 18F-FDG PET
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
August 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Comparison of the detection sensitivity of IE outbreaks between 18F-FDG PET/CT performed with the low carbohydrate diet and conventional diet performed
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.
Characterization of metabolic changes generated by the low carbohydrate diet using plasma bioassays (blood glucose, insulinemia, free fatty acid concentration, ß-hydroxybutyrate).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Endocarditis
Keywords
Infective endocarditis, PET/CT 18F-FDG, Low carbohydrate diet as Atkins diet
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
enrolled patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT
Other Intervention Name(s)
18F-FDG PET/CT
Intervention Description
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
Primary Outcome Measure Information:
Title
Infectious focus 18F-FDG activity measured with SUV (standardized uptake value )
Description
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 Outcome Measure Information:
Title
Visual analysis to detect and locate infective area
Description
each infectious focus will be appreciated by visual reading
Time Frame
24 hours
Title
SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..)
Description
Measure of 18F-FDG activity on the target organs
Time Frame
3 days
Title
metabolic biomarker assay: ß-hydroxybutyrate
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie CHEVALIER, MD
Organizational Affiliation
Nuclear medicine department, CHRU NANCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chru Nancy Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Metabolic Preparation by a Low-carbohydrate Diet as Atkins-diet to Help in Detecting Infective Endocarditis by 18F-FDG PET
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