Benefit of a Hospital Intervention in Patients with Hepatic Steatosis (BIPEH)

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Not yet enrolling

Conditions: Hepatic Steatosis

Treatments: Other: Usual Follow-Up; Other: Specialized Unit

Study type: Interventional

Funder types: Other

Identifiers

NCT06394206

CSAPG-46

Details and patient eligibility

About

The objective of this clinical trial is to determine whether a specialized consultation for controlling metabolic syndrome effectively treats hepatic steatosis in adults. The primary questions it aims to answer are:

• Does this specialized consultation increase the number of patients with hepatic steatosis who show improvement after one year of clinical follow-up in said consultation?

The improvement of the disease will be assessed through the following parameters:

• liver laboratory tests
• weight loss
• improvement in cholesterol and triglyceride levels. Researchers will compare follow-up in the specialized consultation to standard follow-up to assess the effectiveness of the specialized consultation in treating hepatic steatosis.

Participants will be randomly assigned to two groups. The first group will be visited in the specialized consultation every three months for one year and will continue to receive the rest of their follow-up visits. The second group will undergo their usual follow-up visits but will not be visited in the specialized consultation.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients seen in outpatient gastroenterology clinics with hepatic steatosis.
• Diagnosed with hepatic steatosis through ultrasound or abdominal CT scan
• Mild to moderate fibrosis as assessed by elastography or FibroScan (F1-F3) or with a Fibrosis-4 (FIB-4) Index less than 3.5.
• Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.

Exclusion criteria

• Patients who do not have any hepatic imaging test conducted in the last 5 years.
• Conditions other than hepatic steatosis requiring gastroenterological follow-up.
• Abusive alcohol consumption, defined as weekly intake of > 50 g in women and more than 70 g in men.
• Cognitive or affective disorders limiting the ability to cooperate with study procedures.
• Participation in another clinical trial involving experimental intervention during the period of this trial and/or establishing visit schedules incompatible with this trial.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Specialized Unit

Experimental group

Description:

This group of participants will be visited in the specialized consultation and will continue to receive the rest of their follow-up visits.

Treatment:

Other: Specialized Unit

Other: Usual Follow-Up

Usual Follow-Up

Active Comparator group

Description:

This group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation.

Treatment:

Other: Usual Follow-Up