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临床试验/NCT01771185
NCT01771185Unknown不适用

Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes

University of Sao Paulo0 个研究点目标入组 24 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
24
主要终点
Hb A1a

研究概览

简要总结

Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in ~80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • Uncontrolled diabetes ( A1c>8%)
  • Less than 10 years of history
  • Not taking insulin
  • Ages between 20 and 65 years old
  • BMI between 26-34

排除标准

  • previous abdominal surgery
  • Using insulin

研究组 & 干预措施

Best medical treatment

Active Comparator

Metformin 2 g/day; gliclazide 30 mg

干预措施: Best medical treatment (Metformin ; gliclazide) (Drug)

Duodenal jejunal bypass plus sleeve gastrectomy

Active Comparator

Duodenal jejunal bypass plus sleeve gastrectomy is a metabolic surgical procedure

干预措施: Duodenal jejunal bypass plus sleeve gastrectomy (Procedure)

结局指标

主要结局

Hb A1a

时间窗: 24 mo

Primary endpoints- glycemic control

次要结局

  • Systolic and diastolic blood pressure control(24 mo)
  • fasting glycemic control(24 months)
  • Lipidic control(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo Cohen

Clinical Professor of Surgery

University of Sao Paulo

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