Colonic Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- serum or plasma ghrelin changes during colonic infusion
研究概览
简要总结
The distal ileum and proximal colon, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, are important organs in mediating glycemic control. The proximal colon is not easy to access and the correspond in vivo research remains to be difficult. The investigators intend to recruit subjects who underwent rectal surgery with simultaneous protective ileostomy and evaluate hormone secretion and glycemic excursions via ileostomy glucose or saline infusion, and quantify the glucose absorption rate within the proximal colon.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and postmenopausal females aged 18 - 75 years
- •Body mass index (BMI) 20 - 35 kg/m2
- •With protective ileostomy due to benign or malignant rectal surgery
排除标准
- •History of postoperative adjuvant chemotherapy
- •Other significant illness, including epilepsy, cardiovascular or respiratory disease
- •Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (> 2 times upper limit of normal range))
- •Donation of blood within the previous 3 months
- •Participation in any other research studies within the previous 3 months
- •Females who are pre-menopausal
- •Inability to give informed consent
- •Vegetarians
结局指标
主要结局
serum or plasma ghrelin changes during colonic infusion
时间窗: 180 minutes
concentration of serum or plasma ghrelin (pg/ml)
serum or plasma GLP-1 changes during colonic infusion
时间窗: 180 minutes
concentration of serum or plasma GLP-1 (pmol/L)
serum or plasma GIP changes during colonic infusion
时间窗: 180 minutes
concentration of serum or plasma GIP (pmol/L)
serum or plasma c-peptide changes during colonic infusion
时间窗: 180 minutes
concentration of serum or plasma c-peptide (pmol/L)
serum or plasma insulin changes during colonic infusion
时间窗: 180 minutes
concentration of serum or plasma insulin (pmol/L)
serum or plasma glucagon changes during colonic infusion
时间窗: 180 minutes
concentration of serum or plasma glucagon (pmol/L)
glucose absorption capacity
时间窗: 180 minutes
estimated glucose absorption rate during colonic glucose infusion
次要结局
未报告次要终点
研究者
Sanyuan Hu
Professor
Qilu Hospital of Shandong University