Long Term Change of GLP-1 Insulinotropic Effect After GBP Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Beta Cell Sensitivity (BCS)
研究概览
简要总结
Longitudinal study of beta cell function up to 2 years after GBP surgery. Evaluation of the role of endogenous glucagon-like peptide-1 (GLP-1).
详细描述
The increased prevalence of obesity and type 2 diabetes (T2DM) has resulted in a surge in the number of patients seeking surgical weight loss. Gastric bypass surgery (GBP) results in 30-40% body weight loss with resolution of T2DM in 40-80% of cases. The mechanisms by which T2DM improves after GBP are unclear. Glycemic control occurs long before significant weight loss, suggesting that the nature of the procedure, rather than the weight loss, is responsible for the T2DM improvement. Recent data have singled out the role of the gut hormones known as incretins in diabetes improvement after GBP. The current proposal will study 1) whether the short and long term change in the gut hormone incretins after GBP results in improved insulin secretion in response to the administration of oral and IV glucose, in patients with diabetes undergoing GBP surgery; 2) the factors responsible for diabetes remission - or lack of - after GBP. The investigators wish to apply our finding to define better surgical outcome on diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Patients with a wide range of T2DM (duration, treatment modalities and control, in or not in remission) and scheduled for GBP surgery
- •Blood pressure is under at least moderate control <160/100 mmHg
- •Patients can be on dyslipidemia medications but need fasting triglyceride < 600 mg/dl
- •Patients without recent (last 6 months) history of cardiovascular disease (CVD)
- •BMI > 35 and < 55 kg/m2 prior to GBP surgery
排除标准
- •Active cancer
- •Unstable angina
- •Recent stroke
- •Current therapy that may affect glucose metabolism such as glucocorticoids, HIV medications, etc
- •Active infection
- •Kidney failure
- •Severe liver dysfunction
- •Severe respiratory or cardiac failure
- •History of allergic reaction to exendin 9-39
- •History of pancreatitis, history of cholelithiasis, history of alcoholism
- •Presence of high triglyceride levels (>600 ng/dl)
- •Pregnancy (a pregnancy test will be done prior to enrollment and prior to each procedure in all premenopausal women)
研究组 & 干预措施
Exendin9
Longitudinal study of insulin secretion and sensitivity in patients with type 2 diabetes before and after gastric bypass surgery.
干预措施: Exendin9 (Drug)
结局指标
主要结局
Beta Cell Sensitivity (BCS)
时间窗: at 2 years post GBP surgery
Oral glucose tolerance test (OGTT) will be used to calculate BCS Graded glucose infusion with arginine (GGI) will be used to calculate BCS
次要结局
- Insulin Secretion Rate (ISR) after OGTT(2 years post GBP surgery)
- Insulin Secretion Rate (ISR) after GGI(2 years post GBP surgery)
- Maximal Beta Cell Function(2 years post GBP surgery)
研究者
Blandine Laferrere
Professor of Medicine, Columbia University
Columbia University