Hepatic Steatosis
Conditions
Keywords
Fatty Liver, Metabolic Syndrome
Brief 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.
Interventions
OTHERSpecialized Unit
The participant will be visited every three months for one year
OTHERUsual Follow-Up
The participant will be visited as usual, it means they will be visited at Digestive Consultation
Sponsors
Consorci Sanitari de l'Alt Penedès i Garraf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discharge criteria from the gastroenterology clinic | 1 year | Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on Test de Owliver | 1 year | Change in the Owliver test compared to baseline |
| Change on liver enzymes | 1 year | Change compared to baseline in the liver enzymes (UI/mL) |
| Change on total cholesterol | 1 year | Change compared to baseline in the total cholesterol (mg/dL) |
| Change on LDL- cholesterol | 1 year | Change compared to baseline in the LDL- cholesterol (mg/dL) |
| Change on HDL- cholesterol | 1 year | Change compared to baseline in the HDL- cholesterol (mg/dL) |
| Discharge from the gastroenterology clinic after achieving metabolic control goals | 1 year | Difference in the percentage of patients discharged from the gastroenterology clinic after achieving metabolic control goals |
| Change on Fibrosis-4 Index | 1 year | Change compared to baseline on Fibrosis-4 Index |
| Change on Hepatic Fibrosis | 1 year | Change compared to baseline on Fibroscan score |
| Glycated hemoglobin | 1 yera | In diabetic patients, change compared to baseline on glycated hemoglobin |
| Insulin resistance | 1 year | In patients with insulin resistance, change compared to baseline on Insulin Resistance Index |
| Body Mass Index | 1 year | Change compared to baseline on body mass index |
| Change on triglycerides | 1 year | Change compared to baseline in the triglycerides (mg/dL) |
Countries
Spain
Contacts
Primary ContactLidia Tikhomirova, MD
Backup ContactNoemí Casaponsa
Outcome results
None listed