INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
- Conditions
- Diabetes Mellitus, Type 2Dehydration
- Interventions
- Other: Water Intake
- Registration Number
- NCT04076995
- Lead Sponsor
- Arizona State University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low Water Intake Water Intake Low water intake of 0.5 L/day in males and 0.4 L/day High Water intake Water Intake High water intake of 3.0 L/day in males and 2.0 L/day in females
- Primary Outcome Measures
Name Time Method Area under the curve of Glucose at lunch 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 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 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm) Urinary glucose excretion Entire 11-hour protocol 7:00 am - 6:00 pm Area under the curve of Glucagon at dinner 2-hour window starting right before dinner (4:00 pm - 6:00 pm) Area under the curve of Glucose at Dinner 2-hour window starting right before dinner (4:00 pm - 6:00 pm) Area Under the Curve for Plasma osmolality the entire 11-hour protocol 7:00 am - 6:00 pm Area under the curve of Glucose for the entire experiment 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
- Secondary Outcome Measures
Name Time Method 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 Thirst assessed by Visual analog scale
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 Assessed by Profile of mood state questionnaire
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
Trial Locations
- Locations (1)
Arizona Biomedical Collaborative
🇺🇸Phoenix, Arizona, United States