Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Metabolics of RYGB with Gastrostomy - Insulin
研究概览
简要总结
This study is an investigation of the "metabolomics of RYGB with gastrostomy."
详细描述
The rapid and durable remission of type II diabetes mellitis following the gastric bypass operation challenges the current concepts about the etiology of the disease. The surgery, which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly obese individuals who undergo the operation return to a long-term euglycemia with a prolongation of life and a reduction of health care costs.
The investigators at East Carolina University and those at Johnson and Johnson propose to further complete the profile of the upper gut by extending their observation to three additional human models. The investigators will study patients having the gastric band procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG tube inserted later.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •BMI of 35-65
- •Willing to comply with study requirements and long term follow-up
- •Capable of understanding the requirements and consequences of surgery and the study
- •Is scheduled to have bariatric surgery performed
- •Has a negative pregnancy test
排除标准
- •Repeat gastric bypass procedure
- •Patients who are unable to hold their insulin coverage for 48 hours prior to research visits
- •Patients taking TZDs
结局指标
主要结局
Metabolics of RYGB with Gastrostomy - Insulin
时间窗: 03/25/2009-10/12/2012
The patient will be weighed after voiding. The weight will then be used to determine the amount of insulin to be administered during the minimal model. The following formulas will be used to calculate the insulin dosages: REGULAR INSULIN: body mass (kg) X 0.025 U
Metabolics of RYGB with Gastrostomy - Glucose
时间窗: 03/25/2009-10/12/2012
The patient will be weighed after voiding. The weight will then be used to determine the amount of glucose to be administered during the minimal model. The following formulas will be used to calculate the glucose dosages: GLUCOSE: mls of 50% solution of glucose= body mass (kg) X 0.3g X 2
次要结局
未报告次要终点