The Effect of Bariatric Surgery on Glucose Metabolism and Kidney Function
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients with diabetes remission
研究概览
简要总结
This prospective, single arm, longitudinal study aims to assess the effect of bariatric surgery on glucose metabolism and kidney function.
详细描述
In recent years, it has become apparent that bariatric surgery not only promote dramatic weight loss but improve or eliminate type 2 diabetes (T2D). Furthermore, it has become increasingly clear that glucose homeostasis, which is mainly determined based on insulin secretion and insulin resistance, improves through mechanisms additional to the secondary consequences of weight reduction. We aims to assess the effect of bariatric surgery on glucose control and kidney function, and excavate potential mechanism for those effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥20 years old
- •body mass index ≥27.5 kg/m2, in case of type 2 diabetes
- •body mass index ≥35 kg/m2, in case of non-type 2 diabetes
排除标准
- •Prior complex gastrointestinal surgery, including that of the stomach, small intestine, large intestine, bile duct, pancreas, and spleen; Nissen, and trauma (except hemorrhoidectomy, herniorrhaphy, and appendectomy)
- •Abdominal, thoracic, pelvic, and/or obstetric-gynecologic surgery within 3 months or at the discretion of the Investigator
- •Cardiovascular conditions including significant known coronary artery disease (CAD), uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension (defined as medially treated with the mean of three separate measurements systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
- •Subjects with CAD who were successfully treated with coronary artery bypass graft or percutaneous coronary intervention within 3 months and who have no evidence of active ischemia are eligible
- •Kidney diseases including renovascular hypertension, renal artery stenosis, or end-stage renal disease
- •Known history of chronic liver diseases including liver cirrhosis and alpha-1-antitrypsin deficiency
- •Gastrointestinal disorders including a known history of celiac disease or any other malabsorptive disorders or inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •Psychiatric disorders including dementia, active psychosis, history of suicide attempts, and alcohol or drug abuse within 12 months
- •Severe pulmonary disease defined as forced expiratory volume at one second <50% of the predicted value
- •Anemia defined as hemoglobin <8 in females and 10 in males
- •Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage 1 cancer that was successfully treated are eligible based on the Investigator's discretion
- •Any condition or major illness that in the Investigator's judgement places the subject at undue risk by participating in the study
- •Pregnancy
- •Unable to understand the risks, realistic benefits, and compliance requirements of each program
- •Use of investigational therapy or participation in any other clinical trial within 3 months
- •Plans to move outside South Korea within the next 2 years
研究组 & 干预措施
Bariatric surgery patients
Bariatric patients undergoing sleeve gastrectomy or Roux-en-Y gastric bypass
干预措施: Bariatric surgery (Procedure)
结局指标
主要结局
Proportion of patients with diabetes remission
时间窗: 12 months
Remission (complete): Normal measures of glucose metabolism (HbA1c\<6%, fasting plasma glucose\<100mg/dl) in the absence antidiabetic medication
次要结局
- Percent excess weight loss(3,6,12 months)
- Proportion of patients with hypertension improvement(3,6,12 months)
- Proportion of patients with optimal LDL cholesterol control(3,6,12 months)
- Changes of estimated glomerular filtration rate(3,6,12 months)
- Changes of metabolites profile(3,6,12 months)
研究者
Sungsoo Park
Professor
Korea University Anam Hospital