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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04076995
Acronym
INDIGO-2
Enrollment
7
Registered
2019-09-04
Start date
2019-09-18
Completion date
2019-12-19
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Diabetes Mellitus, Type 2

Keywords

dehydration, vasopressin, copeptin

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

Interventions

Increased water intake during the 11 h protocol

Sponsors

Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Area Under the Curve for Plasma osmolalitythe entire 11-hour protocol 7:00 am - 6:00 pm
Area under the curve of Glucose at lunch2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucose at Dinner2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucose for the entire experiment11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
Area under the curve of Copeptin for the entire experiment11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
Area under the curve of Glucagon at lunch2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucagon at dinner2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Urinary glucose excretionEntire 11-hour protocol 7:00 am - 6:00 pm

Secondary

MeasureTime frameDescription
Area under the curve of Insulin at dinner2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Insulin at lunch2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucagon like peptide 1at lunch2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of plasma cortisolthe entire 11-hour protocol 7:00 am - 6:00 pm
Area under the curve for Thirst ratingthe entire 11-hour protocol 7:00 am - 6:00 pmThirst assessed by Visual analog scale
Mood assessment with a questionnairesingle measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pmAssessed by Profile of mood state questionnaire
Area under the curve of Glucagon like peptide 1 at dinner2-hour window starting right before dinner (4:00 pm - 6:00 pm)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026