Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks-567-kcal VLCD in Severely Obese Patients With BMI ≥ 35kg/m2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The changes in the skeletal muscle mass
研究概览
简要总结
Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class II and III obesity patients.
详细描述
Obesity is a chronic disease associated with chronic inflammation, insulin resistance, dyslipidemia, oxidative stress and increased risk for type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress can lead to base lesions of DNA which could be detected with alkine comet assay and its version with use of formamidopyrimidine DNA glycosylase-endonuclease enzyme in fresh or frozen small volume samples. Dietary caloric restriction has beneficial effects on insulin sensitivity, inflammation, oxidative stress and DNA repair. Very low calorie diet (VLCD) data are scarce, especially on the changing levels of DNA damage.This study will assess the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in individuals with BMI ≥ 35kg/m2 on the level of primary and oxidative DNA damage as well as body composition and biochemical 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 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 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 the body mass index
时间窗: Baseline, after 3 weeks of VLCD
Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured body height (m)
The changes in fasting glucose concentration
时间窗: Baseline, after 3 weeks of VLCD
Concentration of glucose (mmol/L)
The changes in insulin concentration
时间窗: Baseline, after 3 weeks of VLCD
Concentration of insulin (mIU/L)
The changes in urea concentration
时间窗: Baseline, after 3 weeks of VLCD
Concentration of urea (mmol/L)
The changes in HOMA index
时间窗: Baseline, after 3 weeks of VLCD
HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5
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 percent body fat
时间窗: Baseline, after 3 weeks of VLCD
Percent body fat (%) assessed with bioelectrical impedance method
The changes in inflammation parameters
时间窗: Baseline, after 3 weeks of VLCD
Concentration of C-reactive protein (mg/L)
次要结局
- The changes in oxidative DNA damage assessed with FPG comet assay(Baseline, after 3 weeks of VLCD)
- The changes in DNA damage assessed with alkaline comet assay(Baseline, after 3 weeks of VLCD)