Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day)
研究概览
简要总结
After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated primary Roux-en-Y gastric bypass >12 months ago
- •Postoperative weight loss of >60%EBL or <50%EBL.
排除标准
- •Inadequately treated thyroid disease
- •Hemoglobin <6.5 mM
- •Pregnancy or breastfeeding
研究组 & 干预措施
Low EBL
Gastric bypass operated patients with low postoperative excess body weight loss (EBL) <50%.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.
干预措施: Meal tests after saline injection (Other)
Low EBL
Gastric bypass operated patients with low postoperative excess body weight loss (EBL) <50%.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.
干预措施: Meal tests after octreotide injection (Other)
Low EBL
Gastric bypass operated patients with low postoperative excess body weight loss (EBL) <50%.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.
干预措施: Sham feeding (Other)
High EBL
Gastric bypass operated patients with high postoperative excess body weight loss (EBL) >70% matched with respect to age, gender and preoperative BMI in the LowEBL group.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.
干预措施: Meal tests after saline injection (Other)
High EBL
Gastric bypass operated patients with high postoperative excess body weight loss (EBL) >70% matched with respect to age, gender and preoperative BMI in the LowEBL group.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.
干预措施: Meal tests after octreotide injection (Other)
High EBL
Gastric bypass operated patients with high postoperative excess body weight loss (EBL) >70% matched with respect to age, gender and preoperative BMI in the LowEBL group.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding.
干预措施: Sham feeding (Other)
结局指标
主要结局
Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day)
时间窗: 0-240 min
Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day
Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day)
时间窗: 0-240 min
Between groups difference in iAUC PYY after fixed breakfast meal on saline day
Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day)
时间窗: 0-240 min
Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day
次要结局
- Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding)(0-30 min)
- Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day)(240 min)
- Ad libitum food intake(240 min)
研究者
Kirstine Nyvold Bojsen-Moeller
MD, PhD
Hvidovre University Hospital