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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Dehydration
• Intervention / Treatment: Other: Water Intake

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona Biomedical Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve of Glucose at lunch	2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucose at Dinner	2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucose for the entire experiment	11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
Area under the curve of Copeptin for the entire experiment	11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)
Area under the curve of Glucagon at lunch	2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Glucagon at dinner	2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Urinary glucose excretion	Entire 11-hour protocol 7:00 am - 6:00 pm
Area Under the Curve for Plasma osmolality	the entire 11-hour protocol 7:00 am - 6:00 pm

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve of Insulin at lunch		2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of Insulin at dinner		2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucagon like peptide 1 at dinner		2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Area under the curve of Glucagon like peptide 1at lunch		2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Area under the curve of plasma cortisol		the entire 11-hour protocol 7:00 am - 6:00 pm
Area under the curve for Thirst rating	Thirst assessed by Visual analog scale	the entire 11-hour protocol 7:00 am - 6:00 pm
Mood assessment with a questionnaire	Assessed by Profile of mood state questionnaire	single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): December 19, 2019
• Study Completion (ACTUAL): December 19, 2019

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (ACTUAL): September 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: vasopressin; dehydration; copeptin
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Water-Electrolyte Imbalance; Diabetes Mellitus, Type 2; Dehydration
• Other Study ID Numbers: STUDY00010276

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