Benefit of a Hospital Intervention in Patients With Hepatic Steatosis

Hepatic Steatosis Clinical Trial

— BIPEH  

Official title:

Benefit of a Hospital Intervention in Patients With Hepatic Steatosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394206
• Other study ID #: CSAPG-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: Lidia Tikhomirova, MD
• Phone: +34 938960025
• Email: ltikhomirova[@]csapg.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis

Intervention

Other:
• Specialized Unit
The participant will be visited every three months for one year
• Usual Follow-Up
The participant will be visited as usual, it means they will be visited at Digestive Consultation

Locations

Country	Name	City	State
Spain	Consorci Sanitari Alt Penedes i Garraf	Sant Pere De Ribes	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discharge criteria from the gastroenterology clinic	Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study	1 year
Secondary	Discharge from the gastroenterology clinic after achieving metabolic control goals	Difference in the percentage of patients discharged from the gastroenterology clinic after achieving metabolic control goals	1 year
Secondary	Change on Test de Owliver	Change in the Owliver test compared to baseline	1 year
Secondary	Change on liver enzymes	Change compared to baseline in the liver enzymes (UI/mL)	1 year
Secondary	Change on total cholesterol	Change compared to baseline in the total cholesterol (mg/dL)	1 year
Secondary	Change on LDL- cholesterol	Change compared to baseline in the LDL- cholesterol (mg/dL)	1 year
Secondary	Change on HDL- cholesterol	Change compared to baseline in the HDL- cholesterol (mg/dL)	1 year
Secondary	Change on triglycerides	Change compared to baseline in the triglycerides (mg/dL)	1 year
Secondary	Change on Fibrosis-4 Index	Change compared to baseline on Fibrosis-4 Index	1 year
Secondary	Change on Hepatic Fibrosis	Change compared to baseline on Fibroscan score	1 year
Secondary	Glycated hemoglobin	In diabetic patients, change compared to baseline on glycated hemoglobin	1 yera
Secondary	Insulin resistance	In patients with insulin resistance, change compared to baseline on Insulin Resistance Index	1 year
Secondary	Body Mass Index	Change compared to baseline on body mass index	1 year