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Water Deprivation Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01224704
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:

Background:

- One area in which obese and lean individuals may be different is how their bodies handle water balance and thirst. Studies done in animals suggest that individuals with greater body fat may tolerate periods without water better than lean animals. Other research has found a link between the ability to tolerate periods without water and increased body weight. Researchers are interested in studying whether the ability to tolerate periods without water and ability to feel thirst might differ in lean versus obese individuals.

Objectives:

- To evaluate the effects of water deprivation and feelings of thirst in lean and obese individuals.

Eligibility:

- Healthy individuals at least 18 years of age who are either lean (body mass index less than 26 kg/m(2)) or obese (body mass index at least 35 kg/m(2)).

Design:

  • Participants will be screened with a medical history, physical examination, and blood and urine tests.
  • Participants will spend the entire study (13 days) as inpatients at the National Institutes of Health Clinical Center.
  • Participants will have the following tests and procedures:
  • Body composition assessment (using low-level x-rays) to determine the percentage of fat tissue in the body.
  • Oral glucose tolerance test (similar to that often used to diagnose diabetes). Individuals who are suspected to have diabetes will not be allowed to continue with the study.
  • High salt infusion test, in which an infusion of saline (salt water) will be given for 2 hours and participants will respond to questions about how hungry and thirsty they feel during the procedure.
  • Water deprivation test, in which participants will go for 24 hours without water or food and respond to questions about how hungry and thirsty they feel.
  • 24-hour stay in a metabolic chamber to determine how many calories participants burn in a day.
  • A series of questionnaires about participants' eating habits, feelings about food, and personal feelings, as well as computer-based tests involving the performance of various tasks.
  • Measurement of free-living energy using doubly-labeled water, in which participants will drink a sample of water with extra-heavy atoms of hydrogen and oxygen to evaluate the amount of water in the body.
  • 24-hour urine collection.
  • Frequent blood samples, urine collection, and fat tissue biopsies during the various study procedures.
  • After the end of the 13-day study, participants will return after 1 week for a final urine collection.

Condition or disease Intervention/treatment Phase
Obesity Other: Hypertonic saline infusion Other: Water deprivation Early Phase 1

Detailed Description:

The percentage of people with overweight / obesity in the United States has reached very high levels, with 65% of adults over the age of 20 being overweight. Recently, there have been a number of advances in our understanding of the underlying causes of obesity, including greater understanding of both the effects of the environment and effects that are hereditary (i.e., genetic).

One area in which obese versus lean individuals may be different is how their bodies handle water balance and thirst. Studies done in animals suggest that individuals with greater body fat may tolerate periods without water better than lean animals. Thus, at least in animals, others have found a link between ability to tolerate periods without water and increased body weight.

We are studying whether the ability to tolerate periods without water and ability to feel thirst might differ in lean versus obese individuals. To do so, we will ask lean and obese individuals to undergo tests that include a period of approximately 24 hours without drinking any water, and on a separate day a shorter period of an intravenous high salt solution infusion. We will be looking at how the ability to withstand thirst (dehydration), subsequent water intake (rehydration), changes in hormone levels during these periods, and behavioral and physiological responses to thirst and rehydration differ in lean versus obese individuals. We hope that the data gathered from this study will give us more information about important differences in how water balance is regulated in lean versus obese individuals. Understanding these questions may provide new insights into differences between lean and obese individuals.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Thirst and Role of Water/Electrolytes Homeostasis During Water Deprivation in Obesity
Actual Study Start Date : October 19, 2010
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Lean: hypertonic first
Lean: Hypertonic solution at day 6 and water deprivation at day 10
Other: Hypertonic saline infusion
Three percent saline (0.1ml/kg of the lean mass/min) will be infused for 120 minutes.

Other: Water deprivation
24 hour water deprivation

Experimental: Lean: water deprivation first
Lean: Water deprivation at day 6 and hypertonic solution at day 10
Other: Hypertonic saline infusion
Three percent saline (0.1ml/kg of the lean mass/min) will be infused for 120 minutes.

Other: Water deprivation
24 hour water deprivation

Experimental: Obese: hypertonic first
Obese: Hypertonic solution at day 6 and water deprivation at day 10
Other: Hypertonic saline infusion
Three percent saline (0.1ml/kg of the lean mass/min) will be infused for 120 minutes.

Other: Water deprivation
24 hour water deprivation

Experimental: Obese: water deprivation first
Obese: Water deprivation at day 6 and hypertonic solution at day 10
Other: Hypertonic saline infusion
Three percent saline (0.1ml/kg of the lean mass/min) will be infused for 120 minutes.

Other: Water deprivation
24 hour water deprivation




Primary Outcome Measures :
  1. Water intake [ Time Frame: End of 24 hour intervention ]
    Water intake (ml/kg body weight) over the first hour following water deprivation or saline infusion


Secondary Outcome Measures :
  1. Hormonal response [ Time Frame: During and at the end of intervention ]
    Vasopressin, apelin, renin-angiotensis system, natriuretic peptides in blood

  2. Thirst rating [ Time Frame: During and at the end of interventions ]
    Thirst is measured by questionnaire using a visual analog scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Male.
  • Age 18-50 yrs to minimize hormonal influences on thirst perception in aging men.
  • BMI<25 kg/m(2) for the lean group and BMI greater than or equal to 35 kg/m(2) for obese group (but weigh less than 350 pounds to accommodate the DXA scanner) for the obese group.
  • Healthy, as determined by medical history and physical examination, without the exclusions listed below:

EXCLUSION CRITERIA:

History or Clinical Manifestation of:

  • Currently smoking
  • Any medications
  • Weight less than 50kg (as the blood withdrawal limit would be exceeded)
  • Hemoglobin concentration less than 12mg/dl on screening labs
  • Type 1 or type 2 diabetes (according to World Health Organization diagnostic criteria (59))
  • Endocrine disorders (Cushing s disease, pituitary diseases, hypo- or hyperthyroidism, diabetes insipidus, SIADH)
  • Hypertension as diagnosed and treated by an outside physician or by sitting blood pressure measurement, using an appropriate cuff, greater than 140/90 mmHg on two or more occasions
  • Fasting triglyceride concentrations greater than or equal to 500 mg/dl
  • Cardiovascular disease, including coronary heart disease, heart failure, arrhythmias and peripheral arterial disease
  • Liver disease, including cirrhosis, active hepatitis B or C and AST or ALT greater than or equal to 3 times normal
  • Renal disease, as defined by serum creatinine concentrations greater than or equal to 1.5 mg/dl and / or proteinuria greater than 300 mg/day (200 (micro)g/min)
  • Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
  • Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have been clearly cured or, in the opinion of the investigator, carry an excellent prognosis
  • Infectious diseases such as active tuberculosis, HIV (by self report), chronic coccidioidomycoses or other chronic infections
  • Alcohol and/or current use of drugs (more than 2 drinks per day and regular use of drugs such as amphetamines, cocaine, heroin, or marijuana)
  • Psychiatric conditions or behaviors that would be incompatible with safe and successful participation in this study, including claustrophobia and eating disorders such as anorexia or bulimia nervosa

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224704


Locations
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United States, Arizona
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Douglas Chang, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01224704    
Other Study ID Numbers: 999911008
11-DK-N008
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 5, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Hypertonic Saline Infusion
Water Deprivation
Thirst
Water/Electrolytes Homeostasis
Obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight