The Effect of Water Intake on Glucose Regulation

Not Applicable

Withdrawn

• Conditions: Glucose Metabolism Disorders; Water Deprivation; Dehydration (Physiology)
• Interventions: Other: Water intake manipulation

• Registration Number: NCT03765008
• Lead Sponsor: Arizona State University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2019-02-11
• Primary Completion: 2019-04-03
• Study Completion: 2019-04-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

BMI 27.5-35

Exclusion Criteria

• 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)
• fluid balance will be exclusionary such as
• serotonin re-uptake inhibitors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Water intake	Water intake manipulation	5-days of High water intake according to IOM guidelines
Low Water Intake	Water intake manipulation	5-days of Low water intake of 500 mL/day

Primary Outcome Measures

Name	Time	Method
metabolic clearance rate for insulin	220-240 min & 340-360 min of the protocol	metabolic clearance rate for insulin during the euglycemic \& Hyperglycemic clamp
amount of glucose metabolized M	220-240 min & 340-360 min of the protocol	amount of glucose metabolized during the euglycemic \& Hyperglycemic clamp
quantity of glucose metabolized per unit plasma insulin concentration	220-240 min & 340-360 min of the protocol	quantity of glucose metabolized per unit plasma insulin concentration during the euglycemic \& Hyperglycemic clamp
Rate of glucose appearance & disappearance	220-240 min & 340-360 min of the protocol	Rate of glucose appearance \& disappearance during the euglycemic \& Hyperglycemic clamp

Secondary Outcome Measures

Name	Time	Method
glucagon	0 min, 240 min & 360 min of the protocol	glucagon in response to water manipulation
Plasma copeptin	0 min, 240 min & 360 min of the protocol	Plasma copeptin in response to water manipulation
Cortisol	0 min, 240 min & 360 min of the protocol	Cortisol in response to water manipulation