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

February 7, 2020 updated by: Arizona State University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona Biomedical Collaborative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: High Water intake
High water intake of 3.0 L/day in males and 2.0 L/day in females
Other: Water Intake
Increased water intake during the 11 h protocol
ACTIVE_COMPARATOR: Low Water Intake
Low water intake of 0.5 L/day in males and 0.4 L/day
Other: Water Intake
Increased water intake during the 11 h protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
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
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
the entire 11-hour protocol 7:00 am - 6:00 pm

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
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
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
Thirst assessed by Visual analog scale
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
Assessed by Profile of mood state questionnaire
single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00010276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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