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临床试验/NCT03038373
NCT03038373进行中(未招募)不适用

Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery-focused on Beta Cell Function and Insulin Sensitivity Changes

Dasman Diabetes Institute0 个研究点目标入组 80 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
主要终点
Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5%

研究概览

简要总结

The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes in the morbid obese patients after laparoscopic sleeve gastrectomy.

详细描述

In this study four groups including: Group I - Morbid Obese Diabetics, Group II - Morbid Obese Non Diabetics, Group III - Lean Diabetics, and Group IV - Lean Non Diabetics will be studies. The bariatric surgical procedure should include Laparoscopic Sleeve Gastrectomy (LSG). All participants will be assessed by members of a multidisciplinary obesity team including a surgeon, endocrinologist, dietician, and nurse specialist who will usually have input into patient selection.

Briefly the study will be explained to the each participant, and after his/her agreement, the informed Consent Form will be deliver to him/her for completion and signature. Within a week before surgery each enrolled participant of group I and II will be subjected to a medical questionnaire and other routine laboratory analyses before surgery such as fasting glucose, liver, renal, lipid and coagulation profiles. At this time a Mixed Meal Tolerance Test (MMTT) will be performed and blood samples will be collected for further analysis as it is described in the protocol.

Participants in group I and II will be admitted at Dasman Diabetes Institute for post-surgery follow up, performing MMTT, and donating blood samples on days 07, 15, 30, 60, 90, 180, and 360 post-surgery. Adipose, muscle biopsies, and a sample from remnant surgical tissue from these participants will be harvested during of the LSG (days 0). Participants in group I will be asked to monitor their fasting blood glucose level everyday at early morning and the dose of anti-hyperglycemia medications will be adjusted by the recommendation provided by the physician member of team. This data will be recorded as their continuous blood glucose monitoring.

Group III and IV participants, as control groups with no surgical intervention, will be subjected to the medical questionnaire and other routine laboratory analyses and MMTT in just one visit.

All demographic and clinical information collected from the participants will be recorded in the information form identified by identification number (ID number). Only samples from the cases that do not have any post-surgery related complications or not have any emergency clinical condition will be used for genomics and proteomics analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes <5 years
  • male and female,
  • resident of Kuwait,
  • who agreed to participate in the study

排除标准

  • pregnancy,
  • malignancy,
  • type 1 diabetes,
  • type 2 diabetes with more than 5 years,
  • and history with overt heart and/or kidney failure

结局指标

主要结局

Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5%

时间窗: 1 year

Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level \< 7.0 mmol and HbA1c \<6.5%

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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