Oxidative Stress and L-CBMN Cytome Assay Parameters Levels in Severely Obese With BMI ≥ 35kg/m2 After 3 Weeks 567 kcal Hospital Controlled VLCD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- The changes in body mass index
研究概览
简要总结
Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.
详细描述
Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric parameters.
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
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
- 否
入选标准
- •body mass index ≥ 35 kg/m2
排除标准
- •pregnancy
- •actual tumor diseases
- •recent diagnostic or treatment exposures to ionizing radiation in the period of one year
- •individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
结局指标
主要结局
The changes in body mass index
时间窗: Baseline, after 3 weeks of VLCD
Body mass index is calculated by dividing body mass (kg) with square of body height (m)
The changes in the body fat mass
时间窗: Baseline, after 3 weeks of VLCD
Body fat mass (kg) assessed with bioelectrical impedance method
The changes in the skeletal muscle mass
时间窗: Baseline, after 3 weeks of VLCD
Skeletal muscle mass (kg) assessed with bioelectrical impedance method
The changes in the percent body fat
时间窗: Baseline, after 3 weeks of VLCD
Percent body fat (%) assessed with bioelectrical impedance method
The changes in fasting glucose concentration
时间窗: Baseline, after 3 weeks of VLCD
Concentration of glucose (mmol/L)
The changes in urea concentration
时间窗: Baseline, after 3 weeks of VLCD
Concentration of urea (mmol/L)
The changes in lipid profile
时间窗: Baseline, after 3 weeks of VLCD
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
The changes in insulin concentration
时间窗: Baseline, after 3 weeks of VLCD
Concentration of insulin (mIU/L)
The changes in homeostatic model assessment (HOMA) index
时间窗: Baseline, after 3 weeks of VLCD
HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5
The changes in inflammation parameters
时间窗: Baseline, after 3 weeks of VLCD
Concentration of C-reactive protein (mg/L) and total white blood cell count
次要结局
- The changes in oxidative stress(Baseline, after 3 weeks of VLCD)
- The changes in DNA damage(Baseline, after 3 weeks of VLCD)