Mannheim Obesity Pilot Study: Evaluation of Metabolic Und Cardiovascular Risk in Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Metabolic syndrome
研究概览
简要总结
MOPS: Mannheim Obesity Pilot Study
Introduction:
Obesity is a central feature of the metabolic syndrome. With increasing prevalence of overweight and obesity, the incidence of WHO III° obesity will further augment. In this subset of obese patients, metabolic complications and cardiovascular risk are major clinical issues. Epidemiological data show that with increased BMI mortality rises (1). The SOS-Study demonstrated, for the first time, that bariatric surgery and consecutive weight reduction are associated with a decrease in cardiovascular and overall mortality. Significant mortality in this study was caused by cardiovascular events and cancer.
Metabolic Syndrome - MS - Despite varying definitions of the metabolic syndrome, obesity is one of its central features. Depending on the definition used, it can represent an obligate criterion (IDF) or a facultative parameter (WHO and ATP III). Even though not obligate, extreme obesity is a central risk factor for most other parameters of the metabolic syndrome.
Endothelial dysfunction -ED- represents the initial step of atherosclerosis (3). An appropriate measurement is the evaluation by retinal analysis. Epidemiological data demonstrate increased cardiovascular risk with retinal vessel pathology (4).
详细描述
Methods and procedures
Study design:
We conducted a prospective study in obesity WHO III° with consecutive enrollment. The study protocol was approved by the local ethics committee. Patients were recruited within an integrated concept designed for individuals seeking weight reduction. This network encompassed a complex approach by nutrition specialists, bariatric surgeons, endocrinologists, ENT specialists and psychologists. Patients could present themselves at any of the aforementioned specialists for study inclusion. Those who consented were followed, after conventional weight loss (diet, activity) or bariatric surgery 1 year later.
Evaluation:
Using a standardized form, we evaluated the medical and obesity history as well as associated metabolic complications (impaired glucose metabolism, elevated Cholesterol and NASH). We further inquired about regular medication, related diseases and classic cardiovascular risk factors (Framingham risk score: cardiovascular disease, family history of cardiovascular disease, nicotine abuse and arterial hypertension).
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 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obesity WHO I-III
排除标准
- •pregnancy
- •acute vascular event within the last 3 months
结局指标
主要结局
Metabolic syndrome
时间窗: baseline, after 1 and 2 years
Framingham risk score
时间窗: baseline, 1 and 2 years
Subclinical atherosclerosis (IMT)
时间窗: baseline, 1 and 2 years
Endothelial dysfunction
时间窗: baseline, 1 and 2 years
次要结局
- Change in body weight(baseline, 1 and 2 years)
研究者
Alexander Lammert
Dr. med.
Universitätsmedizin Mannheim