CompletedNot Applicable

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

United States7 participantsStarted 2019-09-18

Plain-language 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

Who can participate

Age range

30 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the curve of Glucose at lunch

Timeframe: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

Area under the curve of Glucose at Dinner

Timeframe: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

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)

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)

Area under the curve of Glucagon at lunch

Timeframe: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

Area under the curve of Glucagon at dinner

Timeframe: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

Urinary glucose excretion

Trial details

NCT IDNCT04076995

SponsorArizona State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-19

View on ClinicalTrials.gov More Dehydration trials

Plain-language summary

Who can participate

Age range

30 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area under the curve of Glucose at lunch

Timeframe: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

Area under the curve of Glucose at Dinner

Timeframe: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

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)

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)

Area under the curve of Glucagon at lunch

Timeframe: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

Area under the curve of Glucagon at dinner

Timeframe: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

Urinary glucose excretion