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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04076995
Other study ID # STUDY00010276
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 18, 2019
Est. completion date December 19, 2019

Study information

Verified date February 2020
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date December 19, 2019
Est. primary completion date December 19, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Water Intake
Increased water intake during the 11 h protocol

Locations

Country Name City State
United States Arizona Biomedical Collaborative Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the curve of Glucose at lunch 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Primary Area under the curve of Glucose at Dinner 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Primary 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)
Primary 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)
Primary Area under the curve of Glucagon at lunch 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Primary Area under the curve of Glucagon at dinner 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Primary Urinary glucose excretion Entire 11-hour protocol 7:00 am - 6:00 pm
Primary Area Under the Curve for Plasma osmolality the entire 11-hour protocol 7:00 am - 6:00 pm
Secondary Area under the curve of Insulin at lunch 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)
Secondary Area under the curve of Insulin at dinner 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Secondary Area under the curve of Glucagon like peptide 1 at dinner 2-hour window starting right before dinner (4:00 pm - 6:00 pm)
Secondary 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)
Secondary Area under the curve of plasma cortisol the entire 11-hour protocol 7:00 am - 6:00 pm
Secondary Area under the curve for Thirst rating Thirst assessed by Visual analog scale the entire 11-hour protocol 7:00 am - 6:00 pm
Secondary 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
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