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

Primary Purpose

Dehydration, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water Intake
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dehydration focused on measuring dehydration, vasopressin, copeptin

Eligibility Criteria

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

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

Sites / Locations

  • Arizona Biomedical Collaborative

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Water intake

Low Water Intake

Arm Description

High water intake of 3.0 L/day in males and 2.0 L/day in females

Low water intake of 0.5 L/day in males and 0.4 L/day

Outcomes

Primary Outcome Measures

Area under the curve of Glucose at lunch
Area under the curve of Glucose at Dinner
Area under the curve of Glucose for the entire experiment
Area under the curve of Copeptin for the entire experiment
Area under the curve of Glucagon at lunch
Area under the curve of Glucagon at dinner
Urinary glucose excretion
Area Under the Curve for Plasma osmolality

Secondary Outcome Measures

Area under the curve of Insulin at lunch
Area under the curve of Insulin at dinner
Area under the curve of Glucagon like peptide 1 at dinner
Area under the curve of Glucagon like peptide 1at lunch
Area under the curve of plasma cortisol
Area under the curve for Thirst rating
Thirst assessed by Visual analog scale
Mood assessment with a questionnaire
Assessed by Profile of mood state questionnaire

Full Information

First Posted
August 27, 2019
Last Updated
February 7, 2020
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT04076995
Brief Title
INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Acronym
INDIGO-2
Official Title
INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Diabetes Mellitus, Type 2
Keywords
dehydration, vasopressin, copeptin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Water intake
Arm Type
Experimental
Arm Description
High water intake of 3.0 L/day in males and 2.0 L/day in females
Arm Title
Low Water Intake
Arm Type
Active Comparator
Arm Description
Low water intake of 0.5 L/day in males and 0.4 L/day
Intervention Type
Other
Intervention Name(s)
Water Intake
Intervention Description
Increased water intake during the 11 h protocol
Primary Outcome Measure Information:
Title
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)
Title
Area under the curve of Glucose at Dinner
Time Frame
2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Title
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)
Title
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)
Title
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)
Title
Area under the curve of Glucagon at dinner
Time Frame
2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Title
Urinary glucose excretion
Time Frame
Entire 11-hour protocol 7:00 am - 6:00 pm
Title
Area Under the Curve for Plasma osmolality
Time Frame
the entire 11-hour protocol 7:00 am - 6:00 pm
Secondary Outcome Measure Information:
Title
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)
Title
Area under the curve of Insulin at dinner
Time Frame
2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Title
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)
Title
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)
Title
Area under the curve of plasma cortisol
Time Frame
the entire 11-hour protocol 7:00 am - 6:00 pm
Title
Area under the curve for Thirst rating
Description
Thirst assessed by Visual analog scale
Time Frame
the entire 11-hour protocol 7:00 am - 6:00 pm
Title
Mood assessment with a questionnaire
Description
Assessed by Profile of mood state 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

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: 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
Facility Information:
Facility Name
Arizona Biomedical Collaborative
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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