Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function
29. april 2026 oppdatert av: Itshak Amsalem
The goal of this observational study is to learn if weight loss surgery can lower fat inside the heart muscle and improve how the heart relaxes in adults with obesity.
The main questions it aims to answer are:
Does fat inside the heart muscle decrease after weight loss surgery? Does heart relaxation (diastolic function) improve after surgery? Are changes in heart fat linked to changes in weight, body fat, and blood markers?
Participants who are already planning to have weight loss surgery will take part in this study.
Participants will:
Have a heart CT scan to measure fat in the heart muscle before surgery and about 6 months after surgery Have an ultrasound of the heart (echocardiogram) to check how the heart fills and relaxes Have body composition testing to measure fat and muscle Have blood tests, including routine tests and additional markers related to heart function and metabolism
Researchers will compare each participant's results before and after surgery to see if heart fat decreases and if heart function and blood markers improve.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Observasjonsmessig
Registrering (Antatt)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Itshak Amsalem, MD
- Telefonnummer: +972508229454
- E-post: itshak1a@gmail.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
N/A
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults with obesity who are scheduled to undergo bariatric surgery for standard clinical care at a tertiary medical center.
Participants will be recruited during their preoperative evaluation and will undergo baseline and follow-up assessments, including cardiac imaging and clinical measurements, as part of the study.
Beskrivelse
Inclusion Criteria:
- Adults aged 18 years or older
- Scheduled to undergo bariatric surgery for standard clinical indications
- Left ventricular ejection fraction (LVEF) ≥50%
- Able to undergo cardiac computed tomography (CT)
Exclusion Criteria:
- Left ventricular ejection fraction (LVEF) <50%
- Known cardiomyopathies, including sarcoidosis, amyloidosis, or myocarditis
- Significant valvular heart disease
- Contraindication to cardiac CT (e.g., severe renal dysfunction, contrast allergy)
- Presence of intracardiac or cardiac-related foreign material that may interfere with imaging (e.g., prosthetic valves, pacemakers, prior transcatheter devices)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Adults Undergoing Bariatric Surgery
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in intramyocardial fat content assessed by cardiac CT
Tidsramme: Baseline to 6 months
|
Change in intramyocardial fat quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery
|
Baseline to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation coefficient between change in intramyocardial fat and change in diastolic function grade
Tidsramme: Baseline to 6 months
|
Correlation coefficient (unitless) between change in intramyocardial fat, quantified by cardiac computed tomography (CT) as a percentage of myocardial volume, and change in diastolic function grade assessed by transthoracic echocardiography according to guideline-based criteria
|
Baseline to 6 months
|
|
Change in diastolic function grade
Tidsramme: Baseline to 6 months
|
Change in diastolic function grade assessed by transthoracic echocardiography according to standard guideline-based criteria (including parameters such as E/e', left atrial volume index, and other measures of left ventricular filling pressures) between baseline and 6 months
|
Baseline to 6 months
|
|
Change in body composition
Tidsramme: Baseline to 6 months
|
Change in total fat mass and lean body mass assessed by body composition analysis between baseline and 6 months
|
Baseline to 6 months
|
|
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Tidsramme: Baseline to 6 months
|
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration, measured in pg/mL using standard laboratory assays, between baseline and 6 months
|
Baseline to 6 months
|
|
Change in pericardial fat volume
Tidsramme: Baseline to 6 months
|
Change in pericardial fat volume quantified from cardiac computed tomography (CT) between baseline (pre-surgery) and 6 months after bariatric surgery
|
Baseline to 6 months
|
|
Correlation coefficient between change in intramyocardial fat and change in body weight
Tidsramme: Baseline to 6 months
|
Correlation coefficient (unitless) between change in intramyocardial fat, quantified by cardiac CT as a percentage of myocardial volume, and change in body weight measured in kilograms
|
Baseline to 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
15. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SZMC-0044-26
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
Individual participant data (IPD) sharing is currently undecided.
Any future data sharing will depend on institutional policies, ethical approvals, and applicable data protection regulations.
If shared, only de-identified data will be made available to qualified researchers upon reasonable request.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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