NCT03478098已完成不适用
The Importance of Glycaemic Index and Exercise on Postprandial Glucose Excursions and Gut Hormone Secretion Following Roux-en-Y Gastric Bypass
Kirstine Nyvold Bojsen-Moeller2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention
研究概览
简要总结
The study will evaluate postprandial glucose excursions and gut hormone secretion after ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an acute bout of exercise or rest in gastric bypass operated subjects and matched control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- 是
入选标准
- •Undergone Roux-en-Y gastric bypass (RYGB) without complications at least 12 months prior to inclusion.
- •Achieved > 50% Excess BMI Loss
- •Weight stability (no fluctuations over ± 5 kg the last 3 months)
- •HBA1c < 48 mmol/mol before and after surgery without the use of anti-diabetic medication
- •The participant must be able to ingest the meals
排除标准
- •Low hemoglobin levels (< 6.5 mM)
- •Pregnancy (determined by human chorionic gonadotropin (hCG) test) or breastfeeding
- •Dysregulated thyroid gland affection
- •The use of medication which affects heart frequency (i.e. Beta-blockers)
- •Complications following RYGB consisting of dysphagia or other problems associated with ingestion of normal foods (i.e. vomit, diarrhea or strong abdominal pain).
- •Control group:
- •Inclusion Criteria:
- •Matched with the RYGB patients on gender, age (± 5 years), menopausal state (pre- versus post-menopausal) and BMI (± 3 points).
- •Weight stable ( ± 5 kg during 3 months)
- •HBA1c < 48 mmol/mol
- •Exclusion Criteria:
- •Prior bariatric surgery or prior surgery in the upper gastrointestinal tract.
结局指标
主要结局
Impact of acute bout of exercise on nadir plasma glucose within groups for each intervention
时间窗: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal
Comparison of nadir plasma glucose in response to an acute bout of exercise internally in groups a) RYGB and b) control group
Impact of glycaemic index on nadir plasma glucose within groups for each intervention
时间窗: The lowest plasma glucose concentration at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210 OR 240 min after ingestion of meal
Comparison of nadir plasma glucose in response to meals with high vs low glycaemic index internally in groups a) RYGB and b) control group
次要结局
- Impact of postprandial exercise and meal glycaemic index on peptide YY (PYY) secretion within the groups determined by differences in AUC(AUC for time concentration curve of PYY at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on peptide YY secretion within the groups determined by differences in peak concentration(Highest PYY concentration at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of acute bout of exercise on AUC glucose within groups(AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal)
- Impact of acute bout of exercise on delta-fasting-peak glucose within groups(Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal)
- Impact of glycaemic index on AUC glucose within groups(AUC time-concentration-curve for plasma glucose from 0, 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal)
- Impact of glycaemic index on delta-fasting-peak glucose within groups(Difference between fasting plasma glucose and highest plasma glucose at 5, 10, 15 ,20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 210, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in AUC(AUC for time concentration curve of GLP-1 at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on glucagon-like peptide-1 (GLP-1) secretion within the groups determined by differences in peak concentration(Highest GLP-1 at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on ghrelin secretion within the groups determined by differences in suppression from basal values(Decremental AUC for the time concentration curve of ghrelin at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on glucagon secretion within the groups determined by differences in AUC(AUC for time concentration curve of glucagon at 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in peak concentration(Highest lactate at 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in AUC(AUC for time concentration curve of GIP at 0,10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on glucose-dependent insulinotropic peptide (GIP) secretion within the groups determined by differences in peak concentration(Highest concentration of GIP at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on blood lactate levels within the groups determined by differences in AUC(AUC of the time-concentration curve of lactate at 0, 10, 20, 30, 45, 60, 70, 80, 90, 100, 110, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycemic index on insulin secretion within the groups determined by differences in peak concentration(Highest insulin at 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on insulin secretion within the groups determined by differences in AUC(AUC of time-concentration curve of insulin 0, 10, 20, 30, 35, 60, 90, 120, 150, 180, 240 min after ingestion of meal)
- Impact of postprandial exercise and meal glycaemic index on ad libitum food intake within the groups determined by differences in ingested amount of ad libitum meal in grams(at 240 min following ingestion of test meal)
研究者
Kirstine Nyvold Bojsen-Moeller
Kirstine Nyvold Bojsen-Moeller
Hvidovre University Hospital
研究点 (2)
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