Klinische Und Metabolische Charakterisierung Der Langzeitverläufe Von Adipositas-Patienten Mit Vergleich Von Bariatrisch Operierten zu Nicht Operierten Patienten
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Incidence of prediabetes
研究概览
简要总结
The long-term courses after bariatric surgery are not sufficiently known. Furthermore there is a heterogeneity in postoperative responses.
The aim of this study is to investigate the glycemic course (prediabetes, development of diabetes) of patients with obesity (BMI>=35 kg/m2) who had undergone bariatric surgery compared to patients with obesity who have not. A further aim is to investigate predictors of weight development, development of body composition and insulin sensitivity of patients who had undergone bariatric surgery compared to obesity patients who have not undergone bariatric surgery. The long-term courses after different surgical procedures (Roux-Y vs Sleeve) will be compared.
In this study 300 patients with obesity who had been metabolically characterized in a previous study will be recruited.
These patients are examined (medical history, physical examination including ECG, BIA, weight, height) and metabolically characterized.
Participants without diabetes undergo a glucose tolerance test and fasting blood sampling will be performed in participants with diabetes. All patients complete questionnaires to activity, nutrition, life quality, impulsiveness, depression and eating behavior.
Randomly selected participants will be offered an abdominal fat tissue biopsy. When consent is given, this will be performed at least two days after the glucose tolerance test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the study " Das ADIP-Programm: Charakterisierung adipöser Probanden mittels genauer phänotypischer und genotypischer Klassifizierung"
排除标准
- •BMI < 35 kg/m2 at start of the previous study
- •Women during pregnancy and lactation
- •Patients who are unable to give their consent
- •Patients who have undergone surgery within the last 3 months
- •acute disease or infection within the last 4 months
- •HIV- or hepatitis B/C-positive
- •for biopsy of fat tissue: known coagulation disorder or PTT or INR out of reference range
结局指标
主要结局
Incidence of prediabetes
时间窗: On average 11 years after baseline assessment (previous study).
Prediabetes as determined by fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test).
Incidence of diabetes
时间窗: On average 11 years after baseline assessment (previous study).
Diabetes mellitus as determined by HbA1c, fasting glucose and/or post-challenge glucose (120 min after an 75g oral glucose tolerance test).
次要结局
- Occurence of macrovascular complications(On average 11 years after baseline assessment (previous study).)
- Change in insulin sensitivity(Baseline (previous study) and after an average of 11 year (follow-up visit))
- Change in body weight(Baseline (previous study) and after an average of 11 year (follow-up visit))
- Change in body fat mass(Baseline (previous study) and after an average of 11 year (follow-up visit))
- Occurence of diabetic complications - nephropathy(On average 11 years after baseline assessment (previous study).)
- Occurence of diabetic complications - retinopathy(On average 11 years after baseline assessment (previous study).)
- Occurence of diabetic complications - neuropathy(On average 11 years after baseline assessment (previous study).)
- Change in fat free mass(Baseline (previous study) and after an average of 11 year (follow-up visit))