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

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ClinicalTrials.gov Identifier: NCT04076995
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Arizona State University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Dehydration Diabetes Mellitus, Type 2 Other: Water Intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Estimated Study Start Date : September 16, 2019
Estimated Primary Completion Date : December 29, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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. Area under the curve of Glucose at Dinner [ Time Frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. Area under the curve of Glucagon at dinner [ Time Frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm) ]
  7. Urinary glucose excretion [ Time Frame: Entire 11-hour protocol 7:00 am - 6:00 pm ]
  8. Area Under the Curve for Plasma osmolality [ Time Frame: the entire 11-hour protocol 7:00 am - 6:00 pm ]

Secondary Outcome Measures :
  1. 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. Area under the curve of Insulin at dinner [ Time Frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm) ]
  3. 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) ]
  4. 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) ]
  5. Area under the curve of plasma cortisol [ Time Frame: the entire 11-hour protocol 7:00 am - 6:00 pm ]
  6. 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

  7. 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



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076995


Contacts
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Contact: Adam Seal 479-531-6059 adam.seal@asu.edu

Locations
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United States, Arizona
Arizona Biomedical Collaborative Not yet recruiting
Phoenix, Arizona, United States, 85004
Contact: Adam Seal, MS    479-531-6059    adam.seal@asu.edu   
Contact: Stavros Kavouras, PhD    6028272265    stavros.kavouras@asu.edu   
Sponsors and Collaborators
Arizona State University

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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT04076995     History of Changes
Other Study ID Numbers: STUDY00010276
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arizona State University:
dehydration
vasopressin
copeptin
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Dehydration
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Water-Electrolyte Imbalance
Pathologic Processes