The Role of GLP-1 in Mediating Glucose Reductions After Bariatric Surgery
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Plasma glucose area under the curve
研究概览
简要总结
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.
详细描述
The physiologic mechanisms mediating the glucose-lowering effect of Roux-en-Y Gastric Bypass (RYGB) or post-Vertical Sleeve Gastrectomy (VSG) are unknown. The reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, GLP-1, may play an important role.
The purpose of this study is to evaluate the role of GLP-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the GLP-1 receptor in post-RYGB or post-VSG patients with severe symptomatic hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ages 18-65
- •BMI 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery
排除标准
- •Acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week
- •History of cardiac failure, renal insufficiency (estimated Crcl<30cc/min), hepatic insufficiency, chronic obstructive pulmonary disease, anemia (Hct<30%), or uncontrolled hypertension (SBP>160 or DBP>100)
- •Pregnancy
- •Use of medications that affect glucose metabolism
- •Fasting glucose >150 or HbA1c>7.5 on Metformin
- •Women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or Depo Provera)
- •Active, uncontrolled psychiatric disease
- •Participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.
研究组 & 干预措施
Exendin(9-39)
IV infusion of Exendin (9-39).
干预措施: Exendin (9-39) (Drug)
Placebo
IV infusion of normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Plasma glucose area under the curve
时间窗: 0 to 180 minutes
次要结局
- Plasma insulin area under the curve(0 to 180 minutes)
研究者
Tracey McLaughlin
Associate Professor
Stanford University