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Water Deprivation Protocol

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ClinicalTrials.gov Identifier: NCT01224704
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Tracking Information
First Submitted Date  ICMJE October 19, 2010
First Posted Date  ICMJE October 20, 2010
Last Update Posted Date August 31, 2021
Actual Study Start Date  ICMJE October 19, 2010
Actual Primary Completion Date September 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • Hormonal response [ Time Frame: During and at the end of intervention ]
    Vasopressin, apelin, renin-angiotensis system, natriuretic peptides in blood
  • Thirst rating [ Time Frame: During and at the end of interventions ]
    Thirst is measured by questionnaire using a visual analog scale.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Water Deprivation Protocol
Official Title  ICMJE Assessment of Thirst and Role of Water/Electrolytes Homeostasis During Water Deprivation in Obesity
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Lean: hypertonic first
    Lean: Hypertonic solution at day 6 and water deprivation at day 10
    Interventions:
    • Other: Hypertonic saline infusion
    • Other: Water deprivation
  • Experimental: Lean: water deprivation first
    Lean: Water deprivation at day 6 and hypertonic solution at day 10
    Interventions:
    • Other: Hypertonic saline infusion
    • Other: Water deprivation
  • Experimental: Obese: hypertonic first
    Obese: Hypertonic solution at day 6 and water deprivation at day 10
    Interventions:
    • Other: Hypertonic saline infusion
    • Other: Water deprivation
  • Experimental: Obese: water deprivation first
    Obese: Water deprivation at day 6 and hypertonic solution at day 10
    Interventions:
    • Other: Hypertonic saline infusion
    • Other: Water deprivation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2019)
75
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2010)
44
Actual Study Completion Date  ICMJE March 28, 2019
Actual Primary Completion Date September 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01224704
Other Study ID Numbers  ICMJE 999911008
11-DK-N008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Chang, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 12, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP