DehydrationINDIGO-2NCT04076995
INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
A study testing Water Intake in people with Dehydration and Diabetes Mellitus, Type 2, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Diabetes Mellitus, Type 2
- What is being tested?
- Water Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 19 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
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
- Conditions
- Dehydration, Diabetes Mellitus, Type 2
- Being tested
- Water Intake
- Keywords
- dehydration, vasopressin, copeptin
- Medical subject headings
- Dehydration, Diabetes Mellitus, Type 2, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water IntakeOther
Increased water intake during the 11 h protocol
| Study group | Role | What they receive |
|---|---|---|
| High Water intake | Experimental | High water intake of 3.0 L/day in males and 2.0 L/day in females Receives: Other: Water Intake |
| Low Water Intake | Active comparator | Low water intake of 0.5 L/day in males and 0.4 L/day Receives: Other: Water Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of Glucose at lunch
Measured: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucose at Dinner
Measured: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucose for the entire experiment
Measured: 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
Measured: 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
Measured: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucagon at dinner
Measured: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Urinary glucose excretion
Measured: Entire 11-hour protocol 7:00 am - 6:00 pm
Area Under the Curve for Plasma osmolality
Measured: the entire 11-hour protocol 7:00 am - 6:00 pm
Secondary outcomes (7)
Area under the curve of Insulin at lunch
Measured: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Insulin at dinner
Measured: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucagon like peptide 1 at dinner
Measured: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucagon like peptide 1at lunch
Measured: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of plasma cortisol
Measured: the entire 11-hour protocol 7:00 am - 6:00 pm
Area under the curve for Thirst rating
Thirst assessed by Visual analog scale
Measured: the entire 11-hour protocol 7:00 am - 6:00 pm
Mood assessment with a questionnaire
Assessed by Profile of mood state questionnaire
Measured: single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start18 Sep 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076995
- Sponsor's protocol ID
- STUDY00010276
- Acronym
- INDIGO-2
- Status last verified
- Feb 2020
- First submitted
- 27 Aug 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
- ClinicalTrials.gov ID
- NCT04076995
- Acronym / sponsor ID
- INDIGO-2 / STUDY00010276
- Conditions
- Dehydration, Diabetes Mellitus, Type 2
- Keywords
- dehydration, vasopressin, copeptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Water intake | Experimental | Other: Water IntakeHigh water intake of 3.0 L/day in males and 2.0 L/day in females |
| Low Water Intake | Active comparator | Other: Water IntakeLow water intake of 0.5 L/day in males and 0.4 L/day |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- diabetes HbA1c >6.5%
- impaired liver or kidney function
- cardiovascular disease
- weight change of more than 3 kg in the past month
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water IntakeIncreased water intake during the 11 h protocol | Other | High Water intake, Low Water Intake |
Primary outcome
Area under the curve of Glucose at lunch
Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucose at Dinner
Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucose for the entire experiment
Time frame: 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
Time frame: 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
Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucagon at dinner
Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Urinary glucose excretion
Time frame: Entire 11-hour protocol 7:00 am - 6:00 pm
Area Under the Curve for Plasma osmolality
Time frame: the entire 11-hour protocol 7:00 am - 6:00 pm
7 secondary outcomes
Area under the curve of Insulin at lunch
Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Insulin at dinner
Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucagon like peptide 1 at dinner
Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucagon like peptide 1at lunch
Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of plasma cortisol
Time frame: the entire 11-hour protocol 7:00 am - 6:00 pm
Area under the curve for Thirst rating
Time frame: the entire 11-hour protocol 7:00 am - 6:00 pm
Mood assessment with a questionnaire
Time frame: single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Dehydration
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Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration & Female Life Stages
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Intake in people with Dehydration and Diabetes Mellitus, Type 2, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of Glucose at lunch (time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.