Glucose Metabolism DisordersINDIGO-INCT03765008
The Effect of Water Intake on Glucose Regulation
A study testing Water intake manipulation in people with Glucose Metabolism Disorders and Dehydration (Physiology), run by Arizona State University.
Trial summary
There is a growing body of evidence suggesting low water intake and elevated levels of the hormone vasopressin exacerbate glucose regulation. This project will examine the physiological mechanism by which low water intake impairs glucose homeostasis. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders, Dehydration (Physiology), Water Deprivation
- What is being tested?
- Water intake manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2019to 29 Apr 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
- BMI 27.5-35
Who cannot join
- BMI <27.5 or >35
- high physical activity
- diabetes
- impaired liver or kidney function
- cardiovascular disease
- weight change of more than 3 kg in the past month
Show all 10Show fewer
- pregnancy
- previous surgery on digestive tract (except appendectomy)
- fluid balance will be exclusionary such as
- serotonin re-uptake inhibitors.
About this study
Official title: The Effect of Water Intake on Glucose Regulation: A Pilot Study
There is a growing body of evidence suggesting low water intake and elevated levels of the hormone vasopressin exacerbate glucose regulation. This project will examine the physiological mechanism by which low water intake impairs glucose homeostasis.
In the current proposal we aim to: 1) quantify the degree of glucose impairment as a response to elevated vasopressin due to low water intake and 2) identify the physiological mechanism by which elevated vasopressin, as a response to low water intake, impairs glucose regulation
- Being tested
- Water intake manipulation
- Keywords
- water, vasopressin
- Medical subject headings
- Glucose Metabolism Disorders, Dehydration, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water intake manipulationOther
for 5 days prior to each experiment subjects will undergo manipulation of their water intake.
| Study group | Role | What they receive |
|---|---|---|
| High Water intake | Active comparator | 5-days of High water intake according to IOM guidelines Receives: Other: Water intake manipulation |
| Low Water Intake | Experimental | 5-days of Low water intake of 500 mL/day Receives: Other: Water intake manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of glucose metabolized M
amount of glucose metabolized during the euglycemic \& Hyperglycemic clamp
Measured: 220-240 min & 340-360 min of the protocol
metabolic clearance rate for insulin
metabolic clearance rate for insulin during the euglycemic \& Hyperglycemic clamp
Measured: 220-240 min & 340-360 min of the protocol
quantity of glucose metabolized per unit plasma insulin concentration
quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic \& Hyperglycemic clamp
Measured: 220-240 min & 340-360 min of the protocol
Rate of glucose appearance & disappearance
Rate of glucose appearance \& disappearance during the euglycemic \& Hyperglycemic clamp
Measured: 220-240 min & 340-360 min of the protocol
Secondary outcomes (3)
Plasma copeptin
Plasma copeptin in response to water manipulation
Measured: 0 min, 240 min & 360 min of the protocol
glucagon
glucagon in response to water manipulation
Measured: 0 min, 240 min & 360 min of the protocol
Cortisol
Cortisol in response to water manipulation
Measured: 0 min, 240 min & 360 min of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start11 Feb 2019 (estimated)
- Primary completion3 Apr 2019 (estimated)
- Study completion29 Apr 2019 (estimated)
Why it stopped: Study did not get funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Kavouras, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765008
- Sponsor's protocol ID
- FP00018531
- Acronym
- INDIGO-I
- Status last verified
- Aug 2019
- First submitted
- 3 Dec 2018
- Last updated
- 28 Aug 2019
- 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Water Intake on Glucose Regulation: A Pilot Study
- ClinicalTrials.gov ID
- NCT03765008
- Acronym / sponsor ID
- INDIGO-I / FP00018531
- Keywords
- water, vasopressin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not get funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 11 Feb 2019 (estimated)
- Primary completion
- 3 Apr 2019 (estimated)
- Study completion
- 29 Apr 2019 (estimated)
- First posted
- 5 Dec 2018 (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.
There is a growing body of evidence suggesting low water intake and elevated levels of the hormone vasopressin exacerbate glucose regulation. This project will examine the physiological mechanism by which low water intake impairs glucose homeostasis.
In the current proposal we aim to: 1) quantify the degree of glucose impairment as a response to elevated vasopressin due to low water intake and 2) identify the physiological mechanism by which elevated vasopressin, as a response to low water intake, impairs glucose regulation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Water intake | Active comparator | Other: Water intake manipulation5-days of High water intake according to IOM guidelines |
| Low Water Intake | Experimental | Other: Water intake manipulation5-days of Low water intake of 500 mL/day |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 27.5-35
Key exclusion criteria (10 listed)
- BMI <27.5 or >35
- high physical activity
- diabetes
- impaired liver or kidney function
- cardiovascular disease
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 intake manipulationfor 5 days prior to each experiment subjects will undergo manipulation of their water intake. | Other | High Water intake, Low Water Intake |
Primary outcome
amount of glucose metabolized M
Time frame: 220-240 min & 340-360 min of the protocol
amount of glucose metabolized during the euglycemic \& Hyperglycemic clamp
metabolic clearance rate for insulin
Time frame: 220-240 min & 340-360 min of the protocol
metabolic clearance rate for insulin during the euglycemic \& Hyperglycemic clamp
quantity of glucose metabolized per unit plasma insulin concentration
Time frame: 220-240 min & 340-360 min of the protocol
quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic \& Hyperglycemic clamp
Rate of glucose appearance & disappearance
Time frame: 220-240 min & 340-360 min of the protocol
Rate of glucose appearance \& disappearance during the euglycemic \& Hyperglycemic clamp
3 secondary outcomes
Plasma copeptin
Time frame: 0 min, 240 min & 360 min of the protocol
glucagon
Time frame: 0 min, 240 min & 360 min of the protocol
Cortisol
Time frame: 0 min, 240 min & 360 min of the protocol
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Water intake manipulation in people with Glucose Metabolism Disorders and Dehydration (Physiology), run by Arizona State University.
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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
amount of glucose metabolized M (time frame: 220-240 min & 340-360 min of the protocol). The study lists 4 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 28 Aug 2019.