Serum Ferritin Levels and Metabolic Dysfunction Associated Steatotic Liver Disease

Nonalcoholic Fatty Liver Disease Clinical Trial

— MASLD  

Official title:

Serum Ferritin Levels Can Predict Severity and Longterm Outcomes in Patients With Metabolic Dysfunction Associated Steatotic Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06441409
• Other study ID #: 22218
• Secondary ID: No. 2022JJ40749
• Status: Completed
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: April 2024
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn if serum ferritin levels has correlated with metabolic dysfunction associated steatotic liver disease（MASLD）. It will also learn about the effect of lifestyle intervention on serum ferritin levels and MASLD. The main questions it aims to answer are:

Does serum ferritin levels predict the occurence and development of MASLD? Does liver iron overload has correlated with liver fat deposition? Does serum ferritin levels and MASLD got some degree of remission after weight lose with lifestyle intervention?

Researchers will compare the liver fatty, liver iron depositon and serum ferritin levels after lifestyle intervention using self pre-and post-control .

Participants will:

Receive the lifestyle intervention in outpatient. Visit the clinic once after 6 months for checkups and tests. Keep a diary of their diet.

Description:

The diagnosis of MASLD was based on MRI. The diet scheme was formulated based on the results of body composition analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 18 and 80 years outpatients

Exclusion Criteria:

• previous diagnosis of diabetes acute and chronic complications acute and chronic inflammation long-term history of heavy alcohol consumption

Related Conditions & MeSH terms

• Fatty Liver
• Fertility Disorders
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Behavioral:
• Lifestyle intervention
Patients were intervened with lifestyle only and returned to clinic for tests in 6 months. Lifestyle intervention included the diet and exercise. Diet was an energy-restricted balanced diet. Exercise requires 5 days a week and 30 minutes every day.

Locations

Country	Name	City	State
China	the Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between liver fat and liver iron.	Categorical variables were summarized as numbers (percentages), continuous variables with normal distributions as means (SDs), and continuous variables with non-normal distributions as medians (interquartile ranges [IQRs]). Treatment-induced changes were tested by the paired t test and Wilcoxon signed-rank test, as appropriate. The unpaired t test, Mann-Whitney U test, and Kruskal-Wallis test were used for group comparisons. Correlations between site-specific fat mobilization and clinical outcomes were investigated by calculating Pearson correlation coefficients and Pearson partial correlation coefficients. Two-sided P < 0.05 was considered statistically significant. Statistical analyses were performed using R software version 4.1.2 (http://www.r-project.org/).	Patients were return to hospital for MRI after lifestyle intervention for 6 months.
Primary	The correlation between serum ferritin levels and liver fat.	Categorical variables were summarized as numbers (percentages), continuous variables with normal distributions as means (SDs), and continuous variables with non-normal distributions as medians (interquartile ranges [IQRs]). Treatment-induced changes were tested by the paired t test and Wilcoxon signed-rank test, as appropriate. The unpaired t test, Mann-Whitney U test, and Kruskal-Wallis test were used for group comparisons. Correlations between site-specific fat mobilization and clinical outcomes were investigated by calculating Pearson correlation coefficients and Pearson partial correlation coefficients. Two-sided P < 0.05 was considered statistically significant. Statistical analyses were performed using R software version 4.1.2 (http://www.r-project.org/).	Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
Secondary	The site-specific fat mobilization after 6 months' lifestyle intervention.	defined by percentage MRI-based fat loss. Calculated as (initial measurement minus follow-up measurement) / (initial measurement) × 100 and predefined to be assessed at 6-month follow-up. MRI scans were acquired with an INGENIA ELITION X (Philips Medical Systems Nederland B.V.).	After 6 months intervention, patients were return to hospital for MRI analysis.
Secondary	The effect of lifestyle intervention on weight.	Through self control, carry on the statistical analysis to the results of weight. For brevity, absolute changes of continuous variables were designated ?weight.	After 6 months intervention, patients were return to hospital for Body composition analysis.
Secondary	The effect of lifestyle intervention on fat mass.	Through self control, carry on the statistical analysis to the results of fat mass.For brevity, absolute changes of continuous variables were designated ?VFA(cm2).	After 6 months intervention, patients were return to hospital for MRI analysis.