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

NCT04076995 | Completed

• 1 other identifier: STUDY00010276
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Dehydration; Diabetes Mellitus, Type 2

Keywords

dehydration; vasopressin; copeptin

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• 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

Study Arms (2)

High Water intake

EXPERIMENTAL

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

Other: Water Intake

Low Water Intake

ACTIVE COMPARATOR

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

Other: Water Intake

Interventions

Water Intake OTHER

Increased water intake during the 11 h protocol

High Water intake; Low Water Intake

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• h urine osmolality greater than 800 mmol/kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Dehydration; Diabetes Mellitus, Type 2; Diabetes Insipidus

Interventions

Drinking

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 4, 2019
• Study Start: September 18, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)