CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled / 75 target
Drug / intervention
Hypertonic saline infusion +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01224704
NCT01224704N/ACompletedUpdate Overdue (0.4/mo)Completion was 93mo ago

Assessment of Thirst and Role of Water/Electrolytes Homeostasis During Water Deprivation in Obesity

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Oct 20, 2010·Updated Jun 30, 2026

In Brief

A clinical study evaluating Hypertonic saline infusion and Water deprivation for Obesity. Completed, enrolled 75 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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....

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2010
Enrollment StartOct 19, 2010
Primary CompletionSep 9, 2018
Study CompletionMar 28, 2019
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 15.7 years ago

Arms & Interventions

Lean: hypertonic firstexperimental

Lean: Hypertonic solution at day 6 and water deprivation at day 10

Other: Hypertonic saline infusionOther: Water deprivation
Lean: water deprivation firstexperimental

Lean: Water deprivation at day 6 and hypertonic solution at day 10

Other: Hypertonic saline infusionOther: Water deprivation
Obese: hypertonic firstexperimental

Obese: Hypertonic solution at day 6 and water deprivation at day 10

Other: Hypertonic saline infusionOther: Water deprivation
Obese: water deprivation firstexperimental

Obese: Water deprivation at day 6 and hypertonic solution at day 10

Other: Hypertonic saline infusionOther: Water deprivation

Interventions

Hypertonic saline infusionother

Three percent saline (0.1ml/kg of the lean mass/min) will be infused for 120 minutes.

Water deprivationother

24 hour water deprivation