Trial · NCT07889999
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Hepatic Steatosis According to Imaging | 1 to 7 days | Proportion of participants with MASLD who have hepatic steatosis according to available imaging results. |
| Primary | Proportion of Participants With Liver Fibrosis According to FibroScan | 1 to 7 days | Proportion of participants with MASLD who have liver fibrosis according to FibroScan results. |
| Primary | Proportion of Participants With Liver Cirrhosis According to FibroScan | 1 to 7 days | Proportion of participants with MASLD who have liver cirrhosis according to FibroScan results. |
| Primary | Proportion of Participants With at Least 30% Reduction in ALT From Baseline | 6 months ± 2 weeks | Proportion of participants in the prospective cohort with a decrease in alanine aminotransferase (ALT) of at least 30% from the baseline value at approximately 6 months. |
| Secondary | Proportion of Participants With Abnormal Laboratory Parameters | 1 to 7 days | Proportion of participants with abnormalities in red blood cell count, hemoglobin, leukocytes, platelets, ALT, AST, GGT, bilirubin fractions, alkaline phosphatase, total cholesterol, HDL-C, LDL-C, triglycerides, creatinine, glucose, albumin, insulin, INR, and AFP. |
| Secondary | Proportion of Participants With Cardiometabolic Risk Factors | 1 to 7 days | Proportion of participants with cardiometabolic risk factors, including overweight or obesity; hyperglycemia or type 2 diabetes; triglycerides ≥1.7 mmol/L (≥150 mg/dL) or lipid-lowering treatment; HDL-C ≤1.0 mmol/L (≤39 mg/dL) in men or ≤1.3 mmol/L (≤50 mg/dL) in women or lipid-lowering treatment; and blood pressure ≥130/85 mmHg or treatment for hypertension. |
| Secondary | Proportion of Participants by Eating Behavior Profile Based on the DEBQ | 1 to 7 days | Proportion of participants with different eating behavior profiles according to the Dutch Eating Behavior Questionnaire (DEBQ). |
| Secondary | Proportion of Participants by Degree of Alcohol Misuse Based on AUDIT | 1 to 7 days | Proportion of participants with different degrees of alcohol misuse according to the Alcohol Use Disorders Identification Test (AUDIT). |
| Secondary | Prevalence of Concomitant Diseases in Participants With MASLD | 1 to 7 days | Prevalence of concomitant diseases among participants with MASLD. |
| Secondary | Prevalence of Medication and Dietary Supplement Use in Participants With MASLD | 1 to 7 days | Prevalence of individual medication classes, active substances, and dietary supplements used as current therapy among participants with MASLD. |
| Secondary | Proportion of Participants by Liver Fibrosis Risk Category According to FIB-4 | 1 to 7 days | Proportion of participants classified into different liver fibrosis risk categories, from low to high risk, according to the FIB-4 index. |
| Secondary | Proportion of Participants by Cardiovascular Mortality Risk Category According to SCORE | 1 to 7 days | Proportion of participants classified into different cardiovascular mortality risk categories, from low to very high risk, according to the SCORE Risk index. |
| Secondary | Change in Liver Fibrosis Assessed by FibroScan | 6 months ± 2 weeks | Change from baseline in liver stiffness measured in kilopascals (kPa) by FibroScan at approximately 6 months in participants receiving ursodeoxycholic acid (UDCA). |
| Secondary | Change in Hepatic Steatosis Assessed by FLI and HSI | 6 months ± 2 weeks | Change from baseline in the Fatty Liver Index (FLI) and Hepatic Steatosis Index (HSI) at approximately 6 months in participants receiving UDCA. |
| Secondary | Proportion of Participants With Changes in Protocol-Specified Laboratory Parameters From Baseline | 6 months ± 2 weeks | Proportion of participants with changes from baseline in platelet count, aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), and triglycerides at approximately 6 months |
| Secondary | Proportion of Participants With Changes in Eating Behavior Assessed by the DEBQ | 6 months ± 2 weeks | Proportion of participants receiving UDCA with changes from baseline in eating behavior measures assessed using the Dutch Eating Behavior Questionnaire (DEBQ) at approximately 6 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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