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Completed

NCT Number: NCT04076995

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

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

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Key information

Conditions

Dehydration Diabetes Insipidus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

water intake

Other

Increased water intake during the 11 h protocol

Primary outcomes

  1. Area under the curve of Glucose at lunch

    Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

  2. Area under the curve of Glucose at Dinner

    Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

  3. Area under the curve of Glucose for the entire experiment

    Time frame: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)

  4. Area under the curve of Copeptin for the entire experiment

    Time frame: 11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)

  5. Area under the curve of Glucagon at lunch

    Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

  6. Area under the curve of Glucagon at dinner

    Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

  7. Urinary glucose excretion

    Time frame: Entire 11-hour protocol 7:00 am - 6:00 pm

  8. Area Under the Curve for Plasma osmolality

    Time frame: the entire 11-hour protocol 7:00 am - 6:00 pm

Secondary outcomes

  1. Area under the curve of Insulin at lunch

    Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

  2. Area under the curve of Insulin at dinner

    Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

  3. Area under the curve of Glucagon like peptide 1 at dinner

    Time frame: 2-hour window starting right before dinner (4:00 pm - 6:00 pm)

  4. Area under the curve of Glucagon like peptide 1at lunch

    Time frame: 2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)

  5. Area under the curve of plasma cortisol

    Time frame: the entire 11-hour protocol 7:00 am - 6:00 pm

  6. Area under the curve for Thirst rating

    Time frame: the entire 11-hour protocol 7:00 am - 6:00 pm

    Thirst assessed by Visual analog scale

  7. Mood assessment with a questionnaire

    Time frame: single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm

    Assessed by Profile of mood state questionnaire

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Acronym: INDIGO-2

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2019
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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