The Effect of Water Intake on Glucose Regulation

NCT03765008 | Withdrawn

• 1 other identifier: FP00018531
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is a growing body of evidence suggesting low water intake and elevated levels of the hormone vasopressin exacerbate glucose regulation. This project will examine the physiological mechanism by which low water intake impairs glucose homeostasis. In the current proposal we aim to: 1) quantify the degree of glucose impairment as a response to elevated vasopressin due to low water intake and 2) identify the physiological mechanism by which elevated vasopressin, as a response to low water intake, impairs glucose regulation

Conditions

Glucose Metabolism Disorders; Dehydration (Physiology); Water Deprivation

Keywords

water; vasopressin

Outcome Measures

Primary Outcomes (4)

• amount of glucose metabolized M

  amount of glucose metabolized during the euglycemic \& Hyperglycemic clamp

  220-240 min & 340-360 min of the protocol

• metabolic clearance rate for insulin

  metabolic clearance rate for insulin during the euglycemic \& Hyperglycemic clamp

  220-240 min & 340-360 min of the protocol

• quantity of glucose metabolized per unit plasma insulin concentration

  quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic \& Hyperglycemic clamp

  220-240 min & 340-360 min of the protocol

• Rate of glucose appearance & disappearance

  Rate of glucose appearance \& disappearance during the euglycemic \& Hyperglycemic clamp

  220-240 min & 340-360 min of the protocol

Secondary Outcomes (3)

• Plasma copeptin

  0 min, 240 min & 360 min of the protocol

• glucagon

  0 min, 240 min & 360 min of the protocol

• Cortisol

  0 min, 240 min & 360 min of the protocol

Study Arms (2)

High Water intake

ACTIVE COMPARATOR

5-days of High water intake according to IOM guidelines

Other: Water intake manipulation

Low Water Intake

EXPERIMENTAL

5-days of Low water intake of 500 mL/day

Other: Water intake manipulation

Interventions

Water intake manipulation OTHER

for 5 days prior to each experiment subjects will undergo manipulation of their water intake.

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:

• BMI 27.5-35

You may not qualify if:

• BMI \<27.5 or \>35
• high physical activity
• diabetes
• impaired liver or kidney function
• cardiovascular disease
• weight change of more than 3 kg in the past month
• pregnancy
• previous surgery on digestive tract (except appendectomy)
• serotonin re-uptake inhibitors.

Sponsors & Collaborators

• Arizona State University: lead

MeSH Terms

Conditions

Glucose Metabolism Disorders; Dehydration; Diabetes Insipidus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: February 11, 2019
• Primary Completion: April 3, 2019
• Study Completion: April 29, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share