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Impact of GBS on CVD in Type 2 Diabetes Mellitus

2013年2月4日 更新者:Duke University

Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus

This research is a NIH single site study with the aims to (1) determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2) elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess subjects with T2DM.

Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study includes two groups, subjects undergoing gastric bypass surgery and a control group not undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited.

Basal, 6 and 12 months assessments will include: insulin sensitivity determination, cardiovascular function by echo doppler, and DEXA scan.

This study involves risk-level II procedures, however, the risks inherent to the gastric bypass surgery are not considered study-derived because subjects are enrolled from individuals that have already decided to have this surgery. We will determine protein expression profiles of inflammation-related adipokines in the subcutaneous and intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after surgically induced weight loss.

研究概览

详细说明

Patients with type 2 diabetes mellitus (T2DM) are more likely to die from cardiovascular diseases (CVD) than people without diabetes. Furthermore, Patients with diabetes have not benefited from the advances in the management of CVD and/or its risk factors that have resulted in a decrease in mortality for CVD patients without diabetes. Short-term studies have demonstrated that weight loss in over weight or obese subjects with T2DM is associated with decreased insulin resistance, substantial improvements in glycemic and lipoprotein profile, and reduction in blood pressure. However, Long-term data substantiating that these improvements can be maintained are limited. Obesity, and susceptibility to weight gain, is a chronic condition. Continuous care is required to avoid weight regain especially after intensive weigh loss. Morbidly obese patients with body mass index (BMI) over 35 kg/m2 have significant difficulties maintaining weight loss adequate to resolve obesity-related medical conditions by changes in lifestyle or pharmacologic strategies. Currently, surgical treatment of morbid obesity, termed bariatric surgery, appears to be the only modality that results in significant and sustained weight loss along with reversal of diabetes and improvements in cholesterol biosynthesis, and lipoprotein metabolism in morbidly obese patients. Given these observations, we question if patients with T2DM who undergo gastric bypass surgery will significantly reduce levels of abnormalities in vascular structure and function that are central to the development of atherosclerosis. In specific aim 1, we will determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. . In specific aim 2, we will elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess subjects with T2DM. The proposed study is a prospective cohort clinic trial aimed to evaluate changes over time in cardiovascular structure and function of morbidly obese subjects with T2DM undergoing gastric bypass surgery compared to a matched control group who do not undergo gastric bypass surgery. The results of the proposed study will provide the foundation for a new clinic strategy aimed to prevent the development of CVD in obese patients with T2DM. Furthermore, it will serve as the baseline for future large scale longitudinal studies based on aggregate occurrence of severe cardiovascular events.

研究类型

介入性

注册 (实际的)

84

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27704
        • Duke University Health System

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion criteria:

  • Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0%
  • Current regular use of insulin
  • Current regular use of oral hypoglycemic medication.
  • Documented diabetes by current ADA criteria (98).
  • Body mass index ≥ 35 kg/m2 in accord with the 1991 NIH obesity surgery consensus conference criteria and stable weight for the previous 3 months
  • Age between 18-60 years old.
  • Ability and willingness to provide informed consent.
  • No expectation that subject will be moving out of the area of the clinical center during the next 12 months.

Exclusion criteria:

  • Presence of CVD defined as: CAD, electrocardiographic criteria for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease
  • Significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy)
  • Significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery
  • Pregnancy or planning pregnancy
  • Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl)
  • Uncontrolled hypertension
  • Smoking

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Gastric Bypass Surgery
Gastric Bypass Surgery consists of a laparoscopic approach and includes the creation of an isolated 10-15-ml proximal gastric pouch, a retro-colic, retro-gastric Roux-en-Y gastrojejunostomy with linear stapler technique, a 100-cm Roux-limb, a 30-cm biliopancreatic limb, and a stapled end-side enteroenterostomy.
gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes
有源比较器:Diabetes Support and Education
Diabetes Support and Eduction. Subjects attend three educational/social support sessions for 1 year after enrollment. The educational sessions offered for diabetes support and education including informational sessions on diet/nutrition and exercise. These sessions are informational only and do not teach behavioral self-regulation skills. Different nutrition and exercise topics are covered each session. Education
The subjects will attend three educational/social support sessions for 1 year after enrollment. The educational sessions include informational sessions on diet/nutrition and exercise. These sessions are informational and do not teach behavioral self-regulation skills.
有源比较器:Tissue Control Group
Tissue control group includes subjects who are undergoing other non-gastric bypass abdominal surgery. A pea size piece of omentum and subcutaneous fat will be collected.
During the abdominal surgery we would like to take 5 ml blood from the IV line and small pea-sized samples of the fat tissue just under the skin and around the stomach area. These samples will be stored so that we can compare these tissue with other patients.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with Type 2 Diabetes Mellitus (T2DM)
大体时间:0, 6, 12 months
Patients with T2DM who undergo gastric bypass surgery will significantly reduce mean levels of risk factors for CVD compared with diabetic individuals with the same BMI who maintain their weight.
0, 6, 12 months

次要结果测量

结果测量
措施说明
大体时间
To elucidate the mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obese subjects with T2DM.
大体时间:0, 6, 12 months
The reduction in CVD risk is mediated by changes in the expression and release of inflammatory-related adipokines by the adipose tissue.
0, 6, 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alfonso Torquati, MD、Duke University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年11月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2008年11月6日

首先提交符合 QC 标准的

2008年11月6日

首次发布 (估计)

2008年11月7日

研究记录更新

最后更新发布 (估计)

2013年2月5日

上次提交的符合 QC 标准的更新

2013年2月4日

最后验证

2013年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00006703
  • 5K23DK075907-02 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

gastric bypass surgery的临床试验

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