Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of conversion
研究概览
简要总结
The main goal of this study is to gain a thorough understanding, which specific factors drive the unhealthy sequelae of obesity. Therefore, the investigators want to understand:
- What distinguishes obese persons without metabolic diseases from those with medical diseases in a cross-sectional comparison?
- Which factors drive the conversions from metabolically healthy obesity into a metabolically unhealthy obesity in a longitudinal approach?
详细描述
The hypothesis is, that changes in the molecular regulation of adipose tissue as well as in adipose tissue cellular composition are responsible for the development of a rather metabolic healthy or unhealthy phenotype. Knowledge of these factors will be used to generate new diagnostic concepts for personalized risk prediction and will furthermore serve as the basis to develop novel strategies to target adipose tissue to improve metabolic health.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form
- •Age between 18 and 60 years
- •BMI 30-50 kg/m2
- •Knowledge of German, which requires sufficient written and allow oral patient education
- •Inclusion criteria for initially healthy group
- •Blood pressure < 140/90 mmHg
- •Normal glucose metabolism
- •HbA1c < 6.5 %
- •Fasting Glucose < 7.0 mmol/l
- •Normal lipid metabolism
- •o LDL-cholesterol < 5.0 mmol/l
- •≤ 2 of the following metabolic syndrome criteria combined (excluding waist circumference)
- •TG > 1.7 mmol/l
- •HDL-cholesterol > 1.0 mmol/l (male) / > 1.3 mmol/l (female)
- •Fasting glucose ≥ 5.6 mmol/l
- •BP ≥ 130/85 mmHg
排除标准
- •Pregnancy
- •Medication and / or pathologies that prevent a safe execution of the fat tissue biopsies
- •History of or planned bariatric operation
- •Medical conditions that prevent examinations and testing (e.g. symptomatic cardiovascular diseases)
- •Active Malignant tumor (<2a remission)
结局指标
主要结局
Rate of conversion
时间窗: Conversion will be driven by the occurrence of pathological findings caused by obesity (metabolic or cardiovascular pathologies). Through study completion, an average of 1 year.
The primary endpoint is the conversion (through study completions, 10 years) from obese but metabolically healthy subjects into obese patients in a pathological metabolic state, through study completion an average of 1 year.
次要结局
- Rate of identification of factors(Conversion will be driven by the occurrence of pathological findings caused by obesity (metabolic or cardiovascular pathologies), through study completion, an average of 1 year.)