NCT01197963终止不适用
A Surgical Approach to the Management of Type II Diabetes Mellitus in Patients With a BMI Between 25-35 kg/m2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Serial Postoperative HgA1c levels
研究概览
简要总结
The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes.
The surgical procedures:
- a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
- ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age- 21-55 years.
- •Body Mass Index between 25-35 kf/m
- •currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
- •Documented HbA1c>7.5% for at least 3 months.
- •Stable weight for 3 months (+/-)
- •Evidence of stable medical treatment for diabetes over the past 12 months.
- •Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -
排除标准
- •Type I diabetes/juvenile onset
- •C-Peptid levels below 1.0 ng/ml
- •Previous major upper abdominal surgery
- •-Pregnant or plans to become pregnant with in the next 12 months
- •Current Malignancy
- •Severe pulmonary, cardia, or renal disease
- •Eating disorders such as bulimia or binge-eating
- •Severe mental health disorders such as schizophrenia and bipolar disorder
- •Obesity due to other metabolic disorders
- •taking appetite suppressants
- •currently abusing illicit drugs,alcohol or using tobacco products
- •Unable to provide informed consent
- •Unwillingness or unable to comply with study procedures
- •any condition that deems them unsuitable for the study in the opinion of the investigators
结局指标
主要结局
Serial Postoperative HgA1c levels
时间窗: 1 month intervals for 3 months then every 3 months there after
Effectiveness of the transposition to alleviate hyperglycemia will be measured by following serial post operative HbA1c levels. The change from baseline mearusements will be used to determine the outcome. Type 2 diabetes is considered resolved if there is normalization of fasting glucose(\<110 mg/dl) normal HbA1c (\<6%) and no need for diabetic medications.
次要结局
- Serial Postoperative Lipid Profiles levels(1 month for the first 3 months then every 3 months there after)
研究者
Brad Snyder
Assistant Professor - Surgery
The University of Texas Health Science Center, Houston
研究点 (2)
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