The Effect of Water Intake on Glucose Regulation

Glucose Metabolism Disorders Clinical Trial

— INDIGO-I  

Official title:

The Effect of Water Intake on Glucose Regulation: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03765008
• Other study ID #: FP00018531
• Status: Withdrawn
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: April 29, 2019

Study information

• Verified date: August 2019
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 29, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Dehydration (Physiology)
• Glucose Metabolism Disorders
• Metabolic Diseases
• Water Deprivation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of glucose metabolized M	amount of glucose metabolized during the euglycemic & Hyperglycemic clamp	220-240 min & 340-360 min of the protocol
Primary	metabolic clearance rate for insulin	metabolic clearance rate for insulin during the euglycemic & Hyperglycemic clamp	220-240 min & 340-360 min of the protocol
Primary	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
Primary	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	Plasma copeptin	Plasma copeptin in response to water manipulation	0 min, 240 min & 360 min of the protocol
Secondary	glucagon	glucagon in response to water manipulation	0 min, 240 min & 360 min of the protocol
Secondary	Cortisol	Cortisol in response to water manipulation	0 min, 240 min & 360 min of the protocol