Effect of Calorie-restricted Balanced Diet on Mobilization of Fat Storage Pools and Iron Deposition in Individuals With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The site-specific fat mobilization after 6 months' lifestyle intervention.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 70 years
- •have a BMI greater than 28.0 kg/m2
- •exhibit abdominal obesity, defined as a waist circumference of at least 90 cm for men and 85 cm for women
- •willing to undergo a 6-month lifestyle intervention
排除标准
- •For newly diagnosed patients with type 2 diabetes: those with fasting blood glucose ≥ 11.1 mmol/L, random blood glucose ≥ 16.7 mmol/L, or HbA1c ≥ 9.0%, or those exhibiting significant hyperglycemic symptoms, who need to start antidiabetic medication treatment immediately;
- •a prior history of pancreatic diseases;
- •combination of drug-induced hepatitis, autoimmune hepatitis, and viral hepatitis;
- •with a definitive diagnosis of diabetes who have already started medication treatment;
- •severe complications from type 2 diabetes or other significant diseases;
- •usage of drugs affecting body weight, insulin sensitivity, or metabolic-associated fatty liver disease in the past three months (such as insulin, glucocorticoids, thiazolidinediones, metformin, SGLT-2 inhibitors, or GLP-1 receptor agonists);
- •with malignant tumors;
- •acute or chronic infection;
- •with elevated transaminase levels of unknown cause;
- •hemochromatosis;
- •with iron deficiency anemia who are receiving iron supplementation;
- •who have donated blood or received a transfusion within the past six months;
- •who have experienced cardiovascular events within the past six months;
- •with acute or chronic blood loss;
- •alcohol dependence, defined as ethanol intake exceeding 140 g/week for men and 70 g/week for women；
- •pregnant and lactating women.
结局指标
主要结局
The site-specific fat mobilization after 6 months' lifestyle intervention.
时间窗: 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.).
The site-specific iron deposition mobilization after 6 months' lifestyle intervention.
时间窗: 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.).
次要结局
- The correlation between liver fat and liver iron.(Patients were return to hospital for MRI and serum tests after lifestyle intervention for 6 months.)