Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06394206

Benefit of a Hospital Intervention in Patients With Hepatic Steatosis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hepatic Steatosis Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specialized Unit

Other

The participant will be visited every three months for one year

Usual Follow-Up

Other

The participant will be visited as usual, it means they will be visited at Digestive Consultation

Primary outcomes

  1. Discharge criteria from the gastroenterology clinic

    Time frame: 1 year

    Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study

Secondary outcomes

  1. Discharge from the gastroenterology clinic after achieving metabolic control goals

    Time frame: 1 year

    Difference in the percentage of patients discharged from the gastroenterology clinic after achieving metabolic control goals

  2. Change on Test de Owliver

    Time frame: 1 year

    Change in the Owliver test compared to baseline

  3. Change on liver enzymes

    Time frame: 1 year

    Change compared to baseline in the liver enzymes (UI/mL)

  4. Change on total cholesterol

    Time frame: 1 year

    Change compared to baseline in the total cholesterol (mg/dL)

  5. Change on LDL- cholesterol

    Time frame: 1 year

    Change compared to baseline in the LDL- cholesterol (mg/dL)

  6. Change on HDL- cholesterol

    Time frame: 1 year

    Change compared to baseline in the HDL- cholesterol (mg/dL)

  7. Change on triglycerides

    Time frame: 1 year

    Change compared to baseline in the triglycerides (mg/dL)

  8. Change on Fibrosis-4 Index

    Time frame: 1 year

    Change compared to baseline on Fibrosis-4 Index

  9. Change on Hepatic Fibrosis

    Time frame: 1 year

    Change compared to baseline on Fibroscan score

  10. Glycated hemoglobin

    Time frame: 1 yera

    In diabetic patients, change compared to baseline on glycated hemoglobin

  11. Insulin resistance

    Time frame: 1 year

    In patients with insulin resistance, change compared to baseline on Insulin Resistance Index

  12. Body Mass Index

    Time frame: 1 year

    Change compared to baseline on body mass index

Study contacts

Contact information is provided by the study sponsor or research team.

Lidia Tikhomirova, MD

CONTACT

[email protected]

+34 938960025

Noemí Casaponsa

CONTACT

[email protected]

+34 938960025 ext. 43197

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Acronym: BIPEH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 1, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.