Importance of Endogenous Glucagon-like Peptide-1 and Glucose-dependent Insulinotropic Polypeptide for Postprandial Glucose Metabolism After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- iAUC glucose
研究概览
简要总结
Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •, surgery groups:
- •Age > 18 years
- •RYGB or SG operation > 12 months prior to inclusion
- •Weight stable (± 3 kg during the last month)
- •HbA1c < 48 mmol/mol before surgery, and no history of diabetes
- •HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
- •Inclusion Criteria, control group:
- •Age > 18 years
- •no former RYGB- or SG operation
- •Weight stable (± 3 kg during the last month)
- •HbA1c < 48 mmol/mol, fasting plasma glucose < 6.1 mmol/l and no history of diabetes
排除标准
- •Thyrotoxicosis or inadequately treated hypothyreosis
- •Hemoglobin < 6.5 mmol/l at inclusion
- •Pregnancy or breast feeding
- •Medication affecting the planned examinations
- •Matching between groups
- •BMI at inclusion and for surgery groups also pre-surgery BMI
研究组 & 干预措施
Gastric bypass operated patients
Four test days in a randomized, patient-blinded, cross-over design
干预措施: Placebo (Other)
Gastric bypass operated patients
Four test days in a randomized, patient-blinded, cross-over design
干预措施: GLP-1 antagonism (Other)
Gastric bypass operated patients
Four test days in a randomized, patient-blinded, cross-over design
干预措施: GIP antagonism (Other)
Gastric bypass operated patients
Four test days in a randomized, patient-blinded, cross-over design
干预措施: GLP-1 and GIP antagonism (Other)
Sleeve gastrectomy operated patients
Four test days in a randomized, patient-blinded cross-over, design
干预措施: GLP-1 antagonism (Other)
Sleeve gastrectomy operated patients
Four test days in a randomized, patient-blinded cross-over, design
干预措施: GIP antagonism (Other)
Sleeve gastrectomy operated patients
Four test days in a randomized, patient-blinded cross-over, design
干预措施: GLP-1 and GIP antagonism (Other)
Sleeve gastrectomy operated patients
Four test days in a randomized, patient-blinded cross-over, design
干预措施: Placebo (Other)
Un-operated controls
Four test days in a randomized, patient-blinded cross-over, design
干预措施: Placebo (Other)
Un-operated controls
Four test days in a randomized, patient-blinded cross-over, design
干预措施: GLP-1 antagonism (Other)
Un-operated controls
Four test days in a randomized, patient-blinded cross-over, design
干预措施: GIP antagonism (Other)
Un-operated controls
Four test days in a randomized, patient-blinded cross-over, design
干预措施: GLP-1 and GIP antagonism (Other)
结局指标
主要结局
iAUC glucose
时间窗: 240 minutes
Main comparison between groups: delta iAUC glucose (iAUC exendin(9-39) test day - iAUC GIP(3-30) test day) in the RYGB group compared to the SG group
次要结局
- Beta-cell glucose sensitivity (β-GS)(240 minutes)
研究者
Morten Gadegaard Hindsø, MD
Principal Investigator
Hvidovre University Hospital