Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Glucose absorption
研究概览
简要总结
After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Uncomplicated RYGB or SG > 12 month prior to inclusion
- •Weight stable (+/- 3 month the last month)
- •Written informed consent
排除标准
- •Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
- •Pregnancy and/or breastfeeding
- •Inadequately treated thyroid disease
- •Serious heart or respiratory illness
- •Haemoglobin < 6,5 mM.
- •Un-operated control group:
- •Inclusion Criteria:
- •Written informed consent
- •Exclusion Criteria:
- •Prior RYGB, SG or complicated upper gastrointestinal surgery
- •Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
- •Pregnancy and/or breastfeeding
- •Inadequately treated thyroid disease
- •Serious heart or respiratory illness
- •Haemoglobin < 6,5 mM.
结局指标
主要结局
Glucose absorption
时间窗: 0 - 360 minutes
Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON
Protein absorption
时间窗: 0 - 360 minutes
Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON
次要结局
- Protein kinetics(0 - 360 minutes)
- Glucagon-like Peptide 1 (GLP-1) secretion(0 - 240 minutes)
- Peptide YY(0-240 minutes)
- Endogenous glucose production(-120 - 360 minutes)
- Glucose absorption(0 - 360 minutes)
- Insulin secretion(0 - 240 minutes)
- Glucose-dependent Insulinotropic Peptide (GIP)(0 - 240 minutes)
- Ghrelin secretion(0 - 240 minutes)
- Lipolysis(-120 - 360)
- Protein absorption(0 - 360 minutes)
- Glucagon secretion(0-240 minutes)
- Glucose kinetics(0 - 360 minutes)
研究者
Maria Saur Svane
MD
Hvidovre University Hospital