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RECRUITINGNANCT05477212

Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.

This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie keto...

Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis•1 locations•View source on ClinicalTrials.gov

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Contacts

Giovanni De Perogla, Prof

CONTACT

0804994635 giovanni.depergola@irccsdebellis.it

Sponsors

Lead Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Collaborators

Francesco Russo
Giuseppe, Riezzo
Michele, Linsalata
Antonella, Orlando
Benedetta, D Attoma
Laura, Prospero
Antonia, Ignazzi
Sara, De Nucci
Raffaele, Cozzolongo
Vito, Giannuzzi
Maria, De Angelis
Giusy Rita, Caponio
Oronzo, Milella
Gianluigi, Giannelli

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. BMI ≥ 30 Kg/m2 or abdominal circumference (waist) \>94 cm in men and \>80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the features that characterize the metabolic syndrome
•2. Age range between 18 and 70 years, both sexes
•3. Diagnosis of hepatic steatosis, formulated on the basis of fibroscan \[CAP (controlled attenuation parameter) \> 238 dB/m(decibel/meter)\], and other recognized criteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosis score).
•3. Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis
•4. Pregnancy or lactation

Exclusion Criteria

•1. Normal and underweight subjects

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 2, 2024Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment30

Start dateApr 2022

Last updatedOct 2, 2024

Condition

Permeability; Increased NAFLD Obesity

Locations shown

Irccs Saverio de Bellis

Castellana Grotte, BARI

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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