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The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.
The primary objective is to determine the effectiveness of noninvasive markers for detect of advanced fibrosis in patients with diagnosis of fatty liver disease.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic detailed information | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease. |
|
| NAFLD Score | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score. |
|
| NAFLD Score plus Transient elastography | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography. |
|
| Transient elastography | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by transient elastography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic detailed information | Other | Electronic detailed information about non alcoholic fatty liver disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Advanced Fibrosis by any diagnostic modality | Evidence of advanced fibrosis, diagnosed by transient elastography (greater than 8 kPa), NAFLD Score above 0.675, liver biopsy or any other non-invasive marker of liver fibrosis. | One year after the diagnosis of steatosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Specialized care | Through telephone follow-up, investigate if the patient attends to gastroenterologist or endocrinologist for examination, diagnostic confirmation or any treatment. | One year after the diagnosis of steatosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medica Sur Clinic & Foundation | Mexico City | Mexico City | 14050 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35585153 | Derived | Chavez-Tapia NC, Barrientos-Gutierrez T, Torres-Ibarra L, Sanchez-Jimenez B, Juarez-Hernandez E, Ramos-Ostos M, Alva-Lopez LF, Uribe M. Incremental levels of diagnostic information incentivize health-seeking in non-alcoholic fatty liver: a randomized clinical trial. Sci Rep. 2022 May 18;12(1):8272. doi: 10.1038/s41598-022-12295-1. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Standard of care |
| No Intervention |
Standard of care for patients with diagnosis of fatty liver by ultrasound. |
| NAFLD Score | Other | diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854 |
|
| Transient elastography | Other | Transient elastography values greater than 8 kPa |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |