NCT03333642Unknown不适用
Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment
Hospital Federal de Bonsucesso2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年11月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Remission of type 2 Diabetes at 24 months
研究概览
简要总结
This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.
详细描述
A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I or overweight. The main objective is to analyse the effect on 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of type 2 diabetes mellitus;
- •Patients of both sexes treated with oral antidiabetic agents and / or insulins,
- •Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks;
- •HbA1c> 7.0%;
- •Age> 20 years and <65 years;
- •Body mass index (BMI) of 25 to 35 kg / m²;
- •Agree to sign the consent form;
排除标准
- •Diabetes mellitus type 1 (anti-glutamic acid decarboxylase(GAD) positive) or anti-GAD negative body with low β-cell function (peptide C after stimulation <0.5 ng / ml);
- •Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months);
- •Malignant neoplasm;
- •Portal hypertension;
- •Difficulty to cooperate with segment;
- •Low ability to understand surgery;
- •Unrealistic expectations of results;
- •Cognitive deficit;
- •Current pregnancy;
- •Moderate or severe mood disorder; severe anxiety; eating disorders (based on Substance-Related Disorders DSM-V criteria);
- •Chemical dependence or alcoholism (based on Substance-Related Disorders DSM-V criteria).
结局指标
主要结局
Remission of type 2 Diabetes at 24 months
时间窗: 2 years
Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications
次要结局
- Control of type 2 diabetes(2 years)
研究者
Leonardo Rocha Ferraz
Surgeon MD
Hospital Federal de Bonsucesso
研究点 (2)
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