跳至主要内容
临床试验/NCT02288351
NCT02288351撤回不适用

Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass

Duke University0 个研究点开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Elevated Glut-1 gene and protein expression levels

研究概览

简要总结

The purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major mechanism for the remission of T2DM following RYGB.

The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Diagnosis of Type 2 Diabetes Mellitus
  • Age between 18 and 65 years of age
  • BMI > 35kg/m²
  • Diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.

排除标准

  • Patients undergoing revision from another bariatric procedure to RYGB
  • Presence of a seizure disorder (GLUT-1 deficiency syndrome)
  • Use of Tricyclic antidepressants
  • Use of tobacco products

结局指标

主要结局

Elevated Glut-1 gene and protein expression levels

时间窗: 2 months

Gene and protein expression levels of GLUT-1 will be analyzed from the specimens obtained intra-operatively (baseline) and at 2 months post-operatively to determine if levels are significantly elevated above baseline. Quantitative real-time PCR and Western blot techniques will be utilized as described in C below.

次要结局

  • Glut-1 level change in fasting glucose(2 months)

研究者

申办方类型
Other
责任方
Sponsor

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