Benefit of a Hospital Intervention in Patients With Hepatic Steatosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorConsorci Sanitari de l'Alt Penedès i Garraf

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Specialized Unit

    Other intervention

    The participant will be visited every three months for one year

  • Usual Follow-Up

    Other intervention

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

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Specialized UnitExperimental treatment 2 interventions
Group B: Usual Follow-UpActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year

Secondary outcomes

1

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

Time frame
1 year
2

Change on Test de Owliver

Change in the Owliver test compared to baseline

Time frame
1 year
3

Change on liver enzymes

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

Time frame
1 year
4

Change on total cholesterol

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

Time frame
1 year

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: