NCT00488423已完成1 期
Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- To assess the effect of gastric by-pass surgery to decrease lipotoxicity.
研究概览
简要总结
MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more are performed postoperatively for a one year period. The associated labwork drawn with the mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone levels.
详细描述
Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Negative pregnancy test if female
- •ADA criteria for diabetes type II
- •Hematocrit > 35 creatinine < 1.9, AST < 3X upper limit of normal, ALT < 3X upper limit of normal, alkaline phos <3X upper limit of normal
- •Eligibility for bariatric surgery based on the NIH and clinical criteria
- •Mentally and legally capable of providing consent
排除标准
- •Lactating females
- •Must not have type I diabetes
- •Systemic steroids taken within 6 months
- •Clinically significant heart disease
- •Recent pulmonary embolism, untreated proliferative retinopathy, renal failure, uncontrolled hypertension, autonomic neuropathy, resting heart rate > 100, neuromuscular or musculoskeletal disease.
结局指标
主要结局
To assess the effect of gastric by-pass surgery to decrease lipotoxicity.
时间窗: One year
次要结局
- To examine the effect of roux-en-Y compared to gastric banding on pancreatic B cell recovery or insulin secretion in response to oral and IV glucose.(One Year)
研究者
研究点 (2)
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