Impact of GBS on CVD in Type 2 Diabetes Mellitus
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
地位
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27704
- Duke University Health System
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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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.
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gastric bypass surgery to induce weight loss in obese patients with type 2 diabetes
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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
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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.
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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.
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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.
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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 |
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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
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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.
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0, 6, 12 months
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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
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The reduction in CVD risk is mediated by changes in the expression and release of inflammatory-related adipokines by the adipose tissue.
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0, 6, 12 months
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合作者和调查者
调查人员
- 首席研究员:Alfonso Torquati, MD、Duke University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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gastric bypass surgery的临床试验
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的