INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Area under the curve of Glucose at lunch
研究概览
简要总结
Previous studies have indicated increased vasopressin due to hypertonic saline infusion impairs glucose regulation. The current study will examine the effect of low water intake on glucose regulation. No currently published study has investigated the acute effect of low water intake on glucose regulation using continuous glucose monitoring over the course of a full day. The aim of the study is to observe the effect of low water intake on glucose regulation in low drinkers. The study will study the glycemic responses to standardized meals in adults during an 11-hour period in two conditions: a) high water intake and b) low water intake. It is hypothesized that the area under the glucose curve will be greater in the low water intake trial as compared to the high water intake trial
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
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy sedentary participants
- •aged 30-55 years
- •body mass 27.5-35.0 kg·m2
- •low water intake less than 1.5 L∙day-1 (male) or 1.0 L∙day-1 (female)
- •24 h urine osmolality greater than 800 mmol/kg
排除标准
- •diabetes HbA1c >6.5%
- •impaired liver or kidney function
- •cardiovascular disease
- •weight change of more than 3 kg in the past month
- •pregnancy
- •previous surgery on digestive tract
- •exercise >4 h/week
结局指标
主要结局
Area under the curve of Glucose at lunch
时间窗: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Copeptin for the entire experiment
时间窗: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
Area under the curve of Glucagon at lunch
时间窗: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Urinary glucose excretion
时间窗: Entire 11-hour protocol 7:00 am - 6:00 pm
Area under the curve of Glucagon at dinner
时间窗: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucose at Dinner
时间窗: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area Under the Curve for Plasma osmolality
时间窗: the entire 11-hour protocol 7:00 am - 6:00 pm
Area under the curve of Glucose for the entire experiment
时间窗: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
次要结局
- Area under the curve of Glucagon like peptide 1at lunch(2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm))
- Area under the curve for Thirst rating(the entire 11-hour protocol 7:00 am - 6:00 pm)
- Mood assessment with a questionnaire(single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm)
- Area under the curve of Insulin at lunch(2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm))
- Area under the curve of Insulin at dinner(2-hour window starting right before dinner (4:00 pm - 6:00 pm))
- Area under the curve of Glucagon like peptide 1 at dinner(2-hour window starting right before dinner (4:00 pm - 6:00 pm))
- Area under the curve of plasma cortisol(the entire 11-hour protocol 7:00 am - 6:00 pm)