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

NCT ID: NCT04076995

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2019-12-19

Brief Summary

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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

Detailed Description

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Conditions

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Dehydration Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High Water intake

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

Group Type EXPERIMENTAL

Water Intake

Intervention Type OTHER

Increased water intake during the 11 h protocol

Low Water Intake

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

Group Type ACTIVE_COMPARATOR

Water Intake

Intervention Type OTHER

Increased water intake during the 11 h protocol

Interventions

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Water Intake

Increased water intake during the 11 h protocol

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Biomedical Collaborative

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00010276

Identifier Type: -

Identifier Source: org_study_id

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