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

Primary Purpose

Glucose Metabolism Disorders, Dehydration (Physiology), Water Deprivation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Water intake manipulation
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders focused on measuring water, vasopressin

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    High Water intake

    Low Water Intake

    Arm Description

    5-days of High water intake according to IOM guidelines

    5-days of Low water intake of 500 mL/day

    Outcomes

    Primary Outcome Measures

    amount of glucose metabolized M
    amount of glucose metabolized during the euglycemic & Hyperglycemic clamp
    metabolic clearance rate for insulin
    metabolic clearance rate for insulin during the euglycemic & Hyperglycemic clamp
    quantity of glucose metabolized per unit plasma insulin concentration
    quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic & Hyperglycemic clamp
    Rate of glucose appearance & disappearance
    Rate of glucose appearance & disappearance during the euglycemic & Hyperglycemic clamp

    Secondary Outcome Measures

    Plasma copeptin
    Plasma copeptin in response to water manipulation
    glucagon
    glucagon in response to water manipulation
    Cortisol
    Cortisol in response to water manipulation

    Full Information

    First Posted
    December 3, 2018
    Last Updated
    August 23, 2019
    Sponsor
    Arizona State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03765008
    Brief Title
    The Effect of Water Intake on Glucose Regulation
    Acronym
    INDIGO-I
    Official Title
    The Effect of Water Intake on Glucose Regulation: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study did not get funded
    Study Start Date
    February 11, 2019 (Anticipated)
    Primary Completion Date
    April 3, 2019 (Anticipated)
    Study Completion Date
    April 29, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Arizona State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucose Metabolism Disorders, Dehydration (Physiology), Water Deprivation
    Keywords
    water, vasopressin

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High Water intake
    Arm Type
    Active Comparator
    Arm Description
    5-days of High water intake according to IOM guidelines
    Arm Title
    Low Water Intake
    Arm Type
    Experimental
    Arm Description
    5-days of Low water intake of 500 mL/day
    Intervention Type
    Other
    Intervention Name(s)
    Water intake manipulation
    Intervention Description
    for 5 days prior to each experiment subjects will undergo manipulation of their water intake.
    Primary Outcome Measure Information:
    Title
    amount of glucose metabolized M
    Description
    amount of glucose metabolized during the euglycemic & Hyperglycemic clamp
    Time Frame
    220-240 min & 340-360 min of the protocol
    Title
    metabolic clearance rate for insulin
    Description
    metabolic clearance rate for insulin during the euglycemic & Hyperglycemic clamp
    Time Frame
    220-240 min & 340-360 min of the protocol
    Title
    quantity of glucose metabolized per unit plasma insulin concentration
    Description
    quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic & Hyperglycemic clamp
    Time Frame
    220-240 min & 340-360 min of the protocol
    Title
    Rate of glucose appearance & disappearance
    Description
    Rate of glucose appearance & disappearance during the euglycemic & Hyperglycemic clamp
    Time Frame
    220-240 min & 340-360 min of the protocol
    Secondary Outcome Measure Information:
    Title
    Plasma copeptin
    Description
    Plasma copeptin in response to water manipulation
    Time Frame
    0 min, 240 min & 360 min of the protocol
    Title
    glucagon
    Description
    glucagon in response to water manipulation
    Time Frame
    0 min, 240 min & 360 min of the protocol
    Title
    Cortisol
    Description
    Cortisol in response to water manipulation
    Time Frame
    0 min, 240 min & 360 min of the protocol

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Water Intake on Glucose Regulation

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