Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Mean Serum Glucose Levels
研究概览
简要总结
This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.
详细描述
Clinical Trial Objective:
The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.
Clinical Trial Design:
This is a prospective, non-randomized, clinical trial.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient is greater than 18 years old;
- •The patient has a BMI > 35;
- •Patient meets standards for bariatric surgery;
排除标准
- •The patient has an incurable malignant or debilitating disease;
- •The patient has been diagnosed with a severe eating disorder;
- •The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years);
- •The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent
结局指标
主要结局
Mean Serum Glucose Levels
时间窗: 30, 60, and 120 minutes at 6, 9, and 12 months post-operatively
Serum glucose levels measured to assess reactive hypoglycemia status
Reactive Hypoglycemia Status
时间窗: 6 months, 9 months, 12 months post-op
Postoperative reactive hypoglycemia was defined as either * serum glucose \<60 mg/dL at least 1 hour after initiation of glucose tolerance testing * serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing
次要结局
- Insulin Resistance(6, 9, and 12 months post-operatively)
- Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing(6, 9, and 12 months post-op)