The Effect of Water Intake on Glucose Regulation (INDIGO-I)

August 23, 2019 updated by: Stavros Kavouras, Arizona State University

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

BMI 27.5-35

Exclusion Criteria:

  • 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
  • pregnancy
  • previous surgery on digestive tract (except appendectomy)
  • fluid balance will be exclusionary such as
  • serotonin re-uptake inhibitors.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Water intake
5-days of High water intake according to IOM guidelines
Other: Water intake manipulation
for 5 days prior to each experiment subjects will undergo manipulation of their water intake.
Experimental: Low Water Intake
5-days of Low water intake of 500 mL/day
Other: Water intake manipulation
for 5 days prior to each experiment subjects will undergo manipulation of their water intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
220-240 min & 340-360 min of the protocol
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
220-240 min & 340-360 min of the protocol
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
220-240 min & 340-360 min of the protocol
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
220-240 min & 340-360 min of the protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma copeptin
Time Frame: 0 min, 240 min & 360 min of the protocol
Plasma copeptin in response to water manipulation
0 min, 240 min & 360 min of the protocol
glucagon
Time Frame: 0 min, 240 min & 360 min of the protocol
glucagon in response to water manipulation
0 min, 240 min & 360 min of the protocol
Cortisol
Time Frame: 0 min, 240 min & 360 min of the protocol
Cortisol in response to water manipulation
0 min, 240 min & 360 min of the protocol

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

February 11, 2019

Primary Completion (Anticipated)

April 3, 2019

Study Completion (Anticipated)

April 29, 2019

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP00018531

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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