NCT06186869 Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
| NCT ID | NCT06186869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-10-02 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity (BMI\>30) and Non-Alcoholic Fatty Liver Disease (NAFLD) (CAP \>248 dB/m).
Eligibility Criteria
Inclusion Criteria: * BMI ≥ 30 kg/m2 or an abdominal circumference (waist) \> 94 cm in men and \> 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterise metabolic syndrome * Age range 18-65 years, both sexes * Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) \> 238 dB/m)). Exclusion Criteria: * Normal and underweight subjects * Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases * Pregnancy or breastfeeding * Subjects with osteoarticular pathologies that may prevent regular exercise * Inability to quantify the degree of NAFLD by Fibroscan * Person not in possession of a medical certificate of fitness for non-competitive physical activity.
Contact & Investigator
Endrit Shahini, MD
PRINCIPAL INVESTIGATOR
IRCCS Saverio de Bellis
Frequently Asked Questions
Who can join the NCT06186869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06186869 currently recruiting?
Yes, NCT06186869 is actively recruiting participants. Contact the research team at endrit.shahini@irccsdebellis.it for enrollment information.
Where is the NCT06186869 trial being conducted?
This trial is being conducted at Castellana Grotte, Italy.
Who is sponsoring the NCT06186869 clinical trial?
NCT06186869 is sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. The principal investigator is Endrit Shahini, MD at IRCCS Saverio de Bellis. The trial plans to enroll 90 participants.
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