Clinical trial NCT04076995: INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Official title: INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Diabetes Mellitus, Type 2
Keywords: dehydration
vasopressin
copeptin
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 7
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area under the curve of Glucose at lunch
timeFrame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
measure: Area under the curve of Glucose at Dinner
timeFrame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
measure: Area under the curve of Glucose for the entire experiment
timeFrame: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
measure: Area under the curve of Copeptin for the entire experiment
timeFrame: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
measure: Area under the curve of Glucagon at lunch
timeFrame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
measure: Area under the curve of Glucagon at dinner
timeFrame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
measure: Urinary glucose excretion
timeFrame: Entire 11-hour protocol 7:00 am - 6:00 pm
measure: Area Under the Curve for Plasma osmolality
timeFrame: the entire 11-hour protocol 7:00 am - 6:00 pm
Secondary outcomes:
measure: Area under the curve of Insulin at lunch
timeFrame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
measure: Area under the curve of Insulin at dinner
timeFrame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
measure: Area under the curve of Glucagon like peptide 1 at dinner
timeFrame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
measure: Area under the curve of Glucagon like peptide 1at lunch
timeFrame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
measure: Area under the curve of plasma cortisol
timeFrame: the entire 11-hour protocol 7:00 am - 6:00 pm
measure: Area under the curve for Thirst rating
timeFrame: the entire 11-hour protocol 7:00 am - 6:00 pm
measure: Mood assessment with a questionnaire
timeFrame: single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
References: