Infective EndocarditisTEPEIRNCT03465098
Evaluation of a Metabolic Preparation by a Low-carbohydrate Diet as Atkins-diet to Help in Detecting Infective Endocarditis by 18F-FDG PET
A study testing Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT in people with Infective Endocarditis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2018to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Low-Carbohydrate Diet to Highlight Easily 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.
Read more
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).
- Conditions
- Infective Endocarditis
- Being tested
- Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT
- Keywords
- Infective endocarditis, PET/CT 18F-FDG, Low carbohydrate diet as Atkins diet
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CTOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (3)
Visual analysis to detect and locate infective area
each infectious focus will be appreciated by visual reading
Measured: 24 hours
SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..)
Measure of 18F-FDG activity on the target organs
Measured: 3 days
metabolic biomarker assay: ß-hydroxybutyrate
impact diet on ß-hydroxybutyrate assay result (Measure of β-HydroxybutyrateB from plasma in µmol/L)
Measured: one week (on PET standard and on PET with Atkins diet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start19 Mar 2018
- Primary completion2 Dec 2020
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elodie CHEVALIER, Central Hospital, Nancy, France
- Investigators
- Elodie CHEVALIER, MD, Principal investigator, Nuclear medicine department, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465098
- Sponsor's protocol ID
- N°IDRCB: 2017-A01104-49
- Acronym
- TEPEIR
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2017
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Low-Carbohydrate Diet to Highlight Easily Infective Endocarditis by 18F-FDG PET
- ClinicalTrials.gov ID
- NCT03465098
- Acronym / sponsor ID
- TEPEIR / N°IDRCB: 2017-A01104-49
- Conditions
- Infective Endocarditis
- Keywords
- Infective endocarditis, PET/CT 18F-FDG, Low carbohydrate diet as Atkins diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enrolled patients | Experimental | Other: Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CTAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CTAlso: 18F-FDG PET/CTThe 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 | enrolled patients |
Primary outcome
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
3 secondary outcomes
Visual analysis to detect and locate infective area
Time frame: 24 hours
SUV (standardized uptake value) of target organs (myocardium, muscles, liver, brain, blood, kidney..)
Time frame: 3 days
metabolic biomarker assay: ß-hydroxybutyrate
Time frame: one week (on PET standard and on PET with Atkins diet)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Infective Endocarditis
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Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
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CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
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Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
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Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elodie CHEVALIER, MD principal investigator
Nuclear medicine department, CHRU NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT in people with Infective Endocarditis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious focus 18F-FDG activity measured with SUV (standardized uptake value ) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.