the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
NCT Number: NCT06441409
The goal of this clinical trial is to learn if calorie-restricted balanced diet could uniquely influence various fat storage pools and iron deposition and explore the relationships between fat or iron deposition loss in specific locations and glucose metabolism. The main questions it aims to answer are:
After lifestyle intervention, which part of the body shows the fastest fat mobilization? Which part shows the slowest fat mobilization? Which area's fat mobilization is most related to the alleviation of glucose metabolism? Is there a relationship between the fat deposition in organs and the iron deposition in organs?
Researchers will compare the liver fat, pancreatic fat, visceral fat, subscutaneous fat, liver and pancrease iron depositon 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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 410013, China
Fat mobilization status is assessed using magnetic resonance, while the relief of glucose metabolism is determined based on the results of the OGTT before and after life style intervention.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: After 6 months intervention, patients were return to hospital for MRI analysis.
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.).
Time frame: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
Defined by percentage MRI-based organ iron content 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.).
Time frame: Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.
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/).
The Third Xiangya Hospital of Central South University
Other
Effect of Calorie-restricted Balanced Diet on Mobilization of Fat Storage Pools and Iron Deposition in Individuals With Obesity
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