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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03765008
Other study ID # FP00018531
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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
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