PHASE 1 The Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- To compare the Blood levels of of glucose, curve of tolerance wing glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin before and after the procedure
研究概览
简要总结
To determine if the omentectomy diminishes hyperglycemia and improves the resistance to the insulin in patients with morbid obesity and propensity to develop to Diabetes Mellitus type 2.
详细描述
To determine the Blood levels of glucose, curve of tolerance to the glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin in patients with Obesity Morbid and that will be put under umbilical surgery and cholecystectomy opened.
To put under them umbilical surgery or Cholecystectomy open with and without omentectomy To compare the Blood levels of of glucose, curve of tolerance wing glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin before and after the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the patients with Obesity Morbid who suffer of hernia umbilical Chronic Cholecystitis Lithiasic non worsened.
- •Patient with age between the 18 to 55 years of age.
- •Both sorts.
- •Patient with index of corporal mass from 30 to
- •Patient with index waist greater or equal hip of 100cm in men and women greater of 88cm.
- •Patient that has a central glucose of 100 to 125mg.
- •Patient that has a tolerance to the glucose of 140 to 200mg.
- •Patient which they have a result of triglyceride in blood of 300 or greater.
- •Patient that has values of LHD below 40 mg/dl.
排除标准
- •Patient that they have I diagnose already established of Diabetes Mellitus type 2 and in medical treatment.
- •Patient with elevation of hepátic enzymes (more than 50% of the superior limits of normality) and/or creatinin in 1,5 serum > mg/Dl.
- •Patient with Diabetic ketoacidosis history.
- •Uso of oral anticoagulants.
- •Positive Test of pregnancy (Human Chorionic Gonadotropin ) for women.
- •Recurrent Infections and at the time of the study.
- •Umbilical Hernia complicated and strangled or Worsened Chronic Cholecystitis.
结局指标
主要结局
To compare the Blood levels of of glucose, curve of tolerance wing glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin before and after the procedure
时间窗: 3 months
次要结局
- To evaluate the metabolic conditions of the subjects of both groups to the 15 days and the month, 6, 12 and 24 months later to the procedure(3 months)