Study for the Investigation of New Individual Risk Profiles and Therapeutic Strategies in Obesity Related Cardiovascular and Metabolic Disorders.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention
研究概览
简要总结
To work against the increasing burden of obesity, the STYJOBS / EDECTA (STYrian Juvenile OBesity Study / Early DetECtion of Atherosclerosis) project was started at the Medical University of Graz in 2003. STYJOBS / EDECTA is a prospective, observational study to improve the understanding of atherosclerosis, cardiovascular risk, immune mediated low grade Inflammation, metabolic changes, and general disease propensity in obesity. The investigation of the "non-biased" early phase is strongly focused.
Based on this information, new and effective strategies for preclinical diagnostics and early intervention are of main interest. We seek a better understanding of critical lipid profiles, chronic immune-mediated inflammation, disturbed adipokine balance, critical adipose tissue topography, addiction like behaviour, genetics/epigenetics, early vascular pathology, and fatty liver disease. Interventional branches of study tested a holistic strategy comprehending sports, and lifestyle modification for efficiency. The investigative spectrum of STYJOBS / EDECTA comprehends also non-obese body weight extremes i.e. underweight/anorectic people.
详细描述
Obesity is dramatically increasing in countries with so called western Lifestyle, whereby juveniles are affected in particular. Atherosclerosis, a major consequence of obesity, starts early in life and results in cardiovascular disease and stroke, the main causes of mortality in industrialized countries. STYJOBS / EDECTA is a prospective, observational study to improve the understanding of obesity associated pathologic conditions by investigation of the "non-biased" early phase.
We aim
To identify "individual metabolic high risk patterns" in obesity by linking lab parameters (adipokines, immune-inflammatory mediators, oxidative "stress" biomarkers, lipoproteins, molecular genetics, epigenetics), individual adipose tissue topography, early vascular damage, life style habits, and clinical data.
The STYJOBS/EDECTA-Database comprehends currently data from 1325 subjects.For each proband 282 variables are available (Clinical, anthropometric, carotis IMT, 82; Laboratory/Biomarkers, 100; Glucose metabolism, liver, kidney function, lipids, oxidative/nitrosative stress, adipokines, gut-brain axis, clotting, Genetic/mitochondrial function/miscellaneous,100), and the results of an early interventional trial by a holistic strategy.
To establish a comprehensive biobank. The STYJOBS/EDECTA-biomaterial resource comprises serum/plasma/DNA left over probes from currently 1256 probands.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •general healthy condition except overweightness/obesity, age below 55 years
排除标准
- •thyroid dysfunction, infections, chronic diseases (e.g. autoimmune, inflammatory), neoplasia
结局指标
主要结局
Anthropometric changes(BMI, SAT-Topography, waist/hipCF, waist to height ratio) during intervention
时间窗: 12 months
次要结局
- Obesity related biomarkers (fasting glucose, insulin, HOMA-index, HbA1c, liver transaminases, inflammatory markers, adipokines, clotting parameters, lipids, oxidative stress markers, Biomarkers related to tryptophan metabolism), performance diagnostics.(12 months)
研究者
Harald Mangge, MD
Professor Dr.med.
Medical University of Graz