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临床试验/NCT04076995
NCT04076995
已完成
不适用

INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers

Arizona State University1 个研究点 分布在 1 个国家目标入组 7 人2019年9月18日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Dehydration
发起方
Arizona State University
入组人数
7
试验地点
1
主要终点
Area under the curve of Glucose at lunch
状态
已完成
最后更新
6年前

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

注册库
clinicaltrials.gov
开始日期
2019年9月18日
结束日期
2019年12月19日
最后更新
6年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Sponsor

入排标准

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)

研究点 (1)

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