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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specialized Unit | Experimental | This group of participants will be visited in the specialized consultation and will continue to receive the rest of their follow-up visits. |
|
| Usual Follow-Up | Active Comparator | This group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specialized Unit | Other | The participant will be visited every three months for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change on Test de Owliver |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lidia Tikhomirova, MD | Contact | +34 938960025 | ltikhomirova@csapg.cat | |
| Noemà Casaponsa | Contact | +34 938960025 | 43197 | recerca@csapg.cat |
| Name | Affiliation | Role |
|---|---|---|
| Lidia Tikhomirova, MD | CSAPG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari Alt Penedes i Garraf | Sant Pere de Ribes | Barcelona | 08810 | Spain |
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
After publication of main results of the study.
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| Usual Follow-Up | Other | The participant will be visited as usual, it means they will be visited at Digestive Consultation |
|
Change in the Owliver test compared to baseline
| 1 year |
| Change on liver enzymes | Change compared to baseline in the liver enzymes (UI/mL) | 1 year |
| Change on total cholesterol | Change compared to baseline in the total cholesterol (mg/dL) | 1 year |
| Change on LDL- cholesterol | Change compared to baseline in the LDL- cholesterol (mg/dL) | 1 year |
| Change on HDL- cholesterol | Change compared to baseline in the HDL- cholesterol (mg/dL) | 1 year |
| Change on triglycerides | Change compared to baseline in the triglycerides (mg/dL) | 1 year |
| Change on Fibrosis-4 Index | Change compared to baseline on Fibrosis-4 Index | 1 year |
| Change on Hepatic Fibrosis | Change compared to baseline on Fibroscan score | 1 year |
| Glycated hemoglobin | In diabetic patients, change compared to baseline on glycated hemoglobin | 1 yera |
| Insulin resistance | In patients with insulin resistance, change compared to baseline on Insulin Resistance Index | 1 year |
| Body Mass Index | Change compared to baseline on body mass index | 1 year |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |