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

Diabetes Mellitus, Type 2 Clinical Trial

— INDIGO-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076995
• Other study ID #: STUDY00010276
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dehydration
• Diabetes Mellitus, Type 2

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