<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03765008</url>
  </required_header>
  <id_info>
    <org_study_id>FP00018531</org_study_id>
    <nct_id>NCT03765008</nct_id>
  </id_info>
  <brief_title>The Effect of Water Intake on Glucose Regulation</brief_title>
  <acronym>INDIGO-I</acronym>
  <official_title>The Effect of Water Intake on Glucose Regulation: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arizona State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a growing body of evidence suggesting low water intake and elevated levels of the&#xD;
      hormone vasopressin exacerbate glucose regulation. This project will examine the&#xD;
      physiological mechanism by which low water intake impairs glucose homeostasis.&#xD;
&#xD;
      In the current proposal we aim to: 1) quantify the degree of glucose impairment as a response&#xD;
      to elevated vasopressin due to low water intake and 2) identify the physiological mechanism&#xD;
      by which elevated vasopressin, as a response to low water intake, impairs glucose regulation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study did not get funded&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 11, 2019</start_date>
  <completion_date type="Anticipated">April 29, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>amount of glucose metabolized M</measure>
    <time_frame>220-240 min &amp; 340-360 min of the protocol</time_frame>
    <description>amount of glucose metabolized during the euglycemic &amp; Hyperglycemic clamp</description>
  </primary_outcome>
  <primary_outcome>
    <measure>metabolic clearance rate for insulin</measure>
    <time_frame>220-240 min &amp; 340-360 min of the protocol</time_frame>
    <description>metabolic clearance rate for insulin during the euglycemic &amp; Hyperglycemic clamp</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quantity of glucose metabolized per unit plasma insulin concentration</measure>
    <time_frame>220-240 min &amp; 340-360 min of the protocol</time_frame>
    <description>quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic &amp; Hyperglycemic clamp</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of glucose appearance &amp; disappearance</measure>
    <time_frame>220-240 min &amp; 340-360 min of the protocol</time_frame>
    <description>Rate of glucose appearance &amp; disappearance during the euglycemic &amp; Hyperglycemic clamp</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma copeptin</measure>
    <time_frame>0 min, 240 min &amp; 360 min of the protocol</time_frame>
    <description>Plasma copeptin in response to water manipulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glucagon</measure>
    <time_frame>0 min, 240 min &amp; 360 min of the protocol</time_frame>
    <description>glucagon in response to water manipulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>0 min, 240 min &amp; 360 min of the protocol</time_frame>
    <description>Cortisol in response to water manipulation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Glucose Metabolism Disorders</condition>
  <condition>Dehydration (Physiology)</condition>
  <condition>Water Deprivation</condition>
  <arm_group>
    <arm_group_label>High Water intake</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5-days of High water intake according to IOM guidelines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Water Intake</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5-days of Low water intake of 500 mL/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water intake manipulation</intervention_name>
    <description>for 5 days prior to each experiment subjects will undergo manipulation of their water intake.</description>
    <arm_group_label>High Water intake</arm_group_label>
    <arm_group_label>Low Water Intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        BMI 27.5-35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &lt;27.5 or &gt;35&#xD;
&#xD;
          -  high physical activity&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  impaired liver or kidney function&#xD;
&#xD;
          -  cardiovascular disease&#xD;
&#xD;
          -  weight change of more than 3 kg in the past month&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  previous surgery on digestive tract (except appendectomy)&#xD;
&#xD;
          -  fluid balance will be exclusionary such as&#xD;
&#xD;
          -  serotonin re-uptake inhibitors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>August 23, 2019</last_update_submitted>
  <last_update_submitted_qc>August 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Arizona State University</investigator_affiliation>
    <investigator_full_name>Stavros Kavouras</investigator_full_name>
    <investigator_title>Professor of Nutrition</investigator_title>
  </responsible_party>
  <keyword>water</keyword>
  <keyword>vasopressin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Dehydration</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03765008
org study id: FP00018531
nct id: NCT03765008
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: amount of glucose metabolized M
time frame: 220-240 min & 340-360 min of the protocol
description: amount of glucose metabolized during the euglycemic & Hyperglycemic clamp
measure: metabolic clearance rate for insulin
time frame: 220-240 min & 340-360 min of the protocol
description: metabolic clearance rate for insulin during the euglycemic & Hyperglycemic clamp
measure: quantity of glucose metabolized per unit plasma insulin concentration
time frame: 220-240 min & 340-360 min of the protocol
description: quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic & Hyperglycemic clamp
measure: Rate of glucose appearance & disappearance
time frame: 220-240 min & 340-360 min of the protocol
description: Rate of glucose appearance & disappearance during the euglycemic & Hyperglycemic clamp
measure: Plasma copeptin
time frame: 0 min, 240 min & 360 min of the protocol
description: Plasma copeptin in response to water manipulation
measure: glucagon
time frame: 0 min, 240 min & 360 min of the protocol
description: glucagon in response to water manipulation
measure: Cortisol
time frame: 0 min, 240 min & 360 min of the protocol
description: Cortisol in response to water manipulation
arm group label: High Water intake
arm group type: Active Comparator
description: 5-days of High water intake according to IOM guidelines
arm group label: Low Water Intake
arm group type: Experimental
description: 5-days of Low water intake of 500 mL/day
intervention type: Other
intervention name: Water intake manipulation
description: for 5 days prior to each experiment subjects will undergo manipulation of their water intake.
arm group label: High Water intake
arm group label: Low Water Intake
criteria: 
gender: All
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Arizona State University
investigator full name: Stavros Kavouras
investigator title: Professor of Nutrition
mesh term: Metabolic Diseases
mesh term: Dehydration
mesh term: Glucose Metabolism Disorders
sharing ipd: No