Early Changes of Diabetes Parameters After Obesity Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of insulin
研究概览
简要总结
The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients.
详细描述
Previous studies have shown, that laparoscopic Roux-en-Y gastric bypass (LRYGB), and also laparoscopic sleeve gastrectomy (LSG) leed to a significant improvement of glucose metabolism and in many cases to a complete remission of diabetes type II in obese patients. It is still unclear which mechanisms underlie these changes. Since the positive effects of bariatric surgery have been investigated within few days after surgical intervention, before significant weight loss has been achieved, the caloric restriction has been discussed as a possible mechanism.
The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients. Therefore, the investigator will examine obese patients with diabetes type II or impaired glucose metabolism regarding possible metabolic changes within few days after bariatric surgery (LSG or LRYGB) or caloric restriction only.
Group I: Patients undergoing LSG; Group II: Patients undergoing LRYGB; Group III (Control group): Patients undergoing caloric restriction;
Dietetic, anthropometric, metabolic and hormonal parameters will be measured. Primary outcome marker is the insulin sensitivity according to Matsuda (MISI).
The project is a prospective, controlled study. Study examinations will be performed before intervention, and one, two, three, four and five days after (start of) intervention, as well after one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI (Body Mass Index) ≥ 35 kg/m2
- •Clinical diagnosis of type II diabetes or impaired glucose metabolism (Prediabetes: HbA1c > 5,7%, fasting glucose in capillary blood > 110 mg/dl - diagnosed by blood glucose test at the first study examination)
- •Regarding the patients of the surgical groups: Indication to surgical therapy of obesity (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass). The indication to surgery is independent of the study. The surgeon decides about that in the clinical routine according to the German S3 guideline.
- •Written consent to participate int he study
排除标准
- •Medication use which affects glucose metabolism, except for diabetes medication (for example: glucocorticoids)
- •Insulin need >1,0 IU/kg/d
- •Experimental diabetes medication within the last three months
- •Pregnancy
- •Gastrointestinal diseases
- •Uncontrolled hypo- or hyperthyroidism
- •Status after bariatric or other gastrointestinal surgery
研究组 & 干预措施
LSG group
Laparoscopic sleeve gastrectomy
干预措施: Laparoscopic sleeve gastrectomy (Other)
LSG group
Laparoscopic sleeve gastrectomy
干预措施: easy digestible diet (Other)
LRYGB group
Laparoscopic Roux-en-Y gastric bypass
干预措施: Laparoscopic Roux-en-Y gastric bypass (Other)
LRYGB group
Laparoscopic Roux-en-Y gastric bypass
干预措施: easy digestible diet (Other)
Control group
Caloric restriction
干预措施: Caloric restriction diet (Other)
结局指标
主要结局
Change of insulin
时间窗: Within 5 days after surgery or 5 days after start of caloric restriction
Blood insulin is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index
Change of blood glucose
时间窗: Within 5 days after surgery or 5 days after start of caloric restriction
Blood glucose is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index
次要结局
未报告次要终点