Duodenal Ileal Interposition With Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications
研究概览
简要总结
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
详细描述
There will be a randomized clinical trial, non-blind, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus), including 40 research subjects with type 2 diabetes mellitus and obesity class I. In order to analise the effect on weight loss and glycemic control after 2 years of follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of type 2 diabetes mellitus
- •Both sexes were treated with oral antidiabetic agents and / or insulin except the current treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase 4 inhibitors
- •Stable antidiabetic medication within the last 8 weeks prior to randomization (V2), if therapy includes insulin, the average daily dose should not have changed by more than 10% in the past 8 weeks
- •HbA1c> 8.0%
- •Age> 20 years and <60 years
- •Body mass index (BMI) of 30 35 kg / m²
- •Agree to sign the consent form
排除标准
- •Type 1 diabetes mellitus (positive for anti-GAD), or GAD negative anti anti body with low β cell function (C-peptide after stimulation <0.5 ng / ml)
- •Current treatment with GLP-1 receptor agonist and / or dipeptidyl peptidase 4 inhibitors
- •Recent vascular event (myocardial infarction, coronary angioplasty or stroke in the past 6 months)
- •Malignant neoplasm
- •Portal hypertension
- •Inability to cooperate with segment
- •Low capacity of understanding surgery
- •Unrealistic expectations of the outcome
- •Cognitive impairment
- •Current pregnancy
- •Moderate or severe mood disorder; severe anxiety; eating disorders (based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria)
- •Chemical dependency or alcoholism (based on DSM-V criteria).
研究组 & 干预措施
ileal interposition sleeve sympathectomy
laparoscopic ileal interposition with sleeve and sympathectomy
干预措施: ileal interposition with sleeve and sympathectomy (Procedure)
结局指标
主要结局
glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications
时间窗: 2 YEARS
Success Rate of Biochemical Resolution of Diabetes at 24 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
次要结局
未报告次要终点
研究者
Luciana El-Kadre
invited clinical professor
Universidade Positivo