A Prospective Study on the Effects of Bariatric Surgery on Blood Pressure in Patients With Obesity and Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of hypertension medication prescription
研究概览
简要总结
Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions such as diabetes. A variety of studies showed that it cause significant weight loss, recovery from diabetes and improvement in cardiovascular risk factors, such as blood pressure. The recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with co morbidities is a candidate for bariatric surgery. However, the patients with diabetes in Chinese has lower BMI than that in west country. Therefore, this research is designed to observe whether bariatric surgery reduce blood pressure in patients with diabetes and relatively lower BMI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 60 years old.
- •Type 2 Diabetes diagnosis defined according to WHO 2006 guideline.
- •Body mass index between 25.0 and 39.9 kg/m2.
排除标准
- •Hypertension ≥ 180/120 mmHg;
- •Type 1 diabetes, other types of diabetes or gestational diabetes;
- •Acute complications of diabetes;
- •Cerebrovascular diseases in the last 6 months.
- •Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months.
- •Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis.
- •Renal diseases: diabetic nephropathy, creatinine clearance < 30 ml/min.
- •Advanced peripheral arterial disease
- •Atrophic gastritis
- •Alcoholism or use of illicit drugs
- •Previous laparotomy
- •Severe hepatic disorders
- •Pregnancy or women not using effective contraceptive methods.
- •Recent neoplasm (< 5 years)
- •Immunosuppressant drugs
- •Unable to understanding and follow the study protocol orientations.
结局指标
主要结局
Reduction of hypertension medication prescription
时间窗: 12 months
Reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after surgery.
次要结局
- Reduction of hypertension medication prescription(1 month to 6 months)
研究者
Zhiming Zhu
Director of the Dept. of Hypertension & Endocrinology
Third Military Medical University