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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00521729 |
This study will examine how body metabolism adjusts to small changes in environmental temperature and how it may be related to weight loss.
Healthy, non-obese individuals between 18 and 60 years of age may be eligible for this study. The study consists of one screening visit and one 5-day admission to the NIH Clinical Center for the following procedures:
Diet: Participants follow a proscribed diet consisting of 50% carbohydrates, 20% protein and 30% fat.
DEXA scan to measure body fat. Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body.
Air displacement plethysmography (Bod-Pod) to study fat composition: Subjects sit in a small booth for 10 minutes wearing a swim suit and breathing normally through a tube. This test measures the person's weight and volume precisely.
Metabolic room: Subjects stay 12 hours in a specialized room designed to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out. The room contains a private toilet and sink, treadmill, bed, desk, window, telephone and computer with television and internet access. While in this room, subjects undergo the following:
Fat tissue biopsy: A small piece of fat tissue is withdrawn through a needle from under the skin on the abdomen. The sample is used to study fat tissue size and ability to store sugar....
Condition | Intervention |
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Obesity |
Procedure: Exposure to Cold Temperature |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Thyroid Hormones Homeostasis and Energy Metabolism Changes During Exposure to Cold Temperature in Humans |
Estimated Enrollment: | 25 |
Study Start Date: | August 2007 |
Thyroid hormones play an important role in the modulation of energy metabolism by regulating the rate of thermogenesis, i.e. the amount of heat produced to maintain the stable core temperature of the organism. Clinically, hypo- and hyperthyroidism are associated with major changes of thermoregulation and energy expenditure. While in rodents the ability of thyroid hormones in regulating the temperature and energy expenditure in response to changes of temperature is well known, its actual role in humans is poorly understood. We hypothesize that humans will respond to exposure to moderate cold by increasing the energy expenditure mediated by the thyroid hormones' action and, at the same time, by decreasing the heat dispersion. This randomized, cross-over study is aimed to analyze the changes in the thyroid hormones, energy expenditure and stress hormones in response to exposure to mild changes in environmental temperature.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
EXCLUSION CRITERIA:
Diabetes mellitus (fasting serum glucose X greater than 126 mg/dL)
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 070202, 07-DK-0202 |
Study First Received: | August 25, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00521729 |
Health Authority: | United States: Federal Government |
Thyroid Thermoregulation Catecholamines Energy Expenditure |
Obesity Healthy Volunteer HV |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Healthy |