Status:
COMPLETED
Body Heat Content and Dissipation in Obese and Normal Weight Adults
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Brief Summary
This study will investigate how different parts of the body lose body heat and will measure the heat released by specific areas such as the limbs and abdomen. Animal studies suggest that dissipation o...
Detailed Description
Animal models suggest that dissipation of body heat is an important physiological process that may affect energy expenditure, and thus may possibly modulate body weight. It is unknown, however, if def...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Volunteers will qualify if they meet the following criteria:
- Good general health. Individuals taking medications for obesity-related co-morbid conditions will generally be excluded, but will be considered on a case-by-case basis. Participants will be nonsmokers.
- Age greater than or equal to 18 years.
- Body Mass Index (BMI) between 18 and 27 kg/m(2) for normal weight subjects or BMI greater than or equal to 30 kg/m(2). To maximize differences between groups, overweight but not obese adults will not be studied. Body weight will be less than 300 pounds (136 kg), however, because DXA scanners at the Clinical Center cannot scan individuals of greater size).
- For women with childbearing potential, a negative pregnancy test at the initial evaluation. Since these subjects have to undergo an X-ray screening, for safety purposes pregnant women will be excluded from participation in the study.
- For women, a normal menstrual cycle or post menopausal status. Women with normal cycles will be studied between 1-3 weeks following their last menstrual period.
- EXCLUSION CRITERIA (Overweight Subjects):
- Volunteers will be excluded (and referred to treatment as needed) for the following reasons:
- Presence of major illnesses: renal (serum creatinine greater than 1.6), hepatic (AST/ALT greater than 3 times upper limit of normal range used in Clinical Center assays), gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or untreated hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication or sleep-apnea related disorders). The presence of the 'hunting' reflex will not exclude patients.
- Pregnancy.
- Individuals who have a current substance abuse, including smoking, or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or compliance, or possibly hinder completion of the study;
- Subjects who regularly use prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting the study. Individuals taking medications for most conditions will be excluded, but medication use will be considered on a case-by-case basis.
- Weight change of more than 3% of body weight in the past two months.
- Areas to be visualized by IR are deemed by the investigators to be too hirsute to allow accurate measurement of underlying tissues.
- Fat depth in areas to be measured is more than 4 cm.
- Long nails that would preclude wearing snug-fitting surgical gloves.
- Weight in excess of 300 lbs (136 kg) that would preclude being scanned by Clinical Center DXA machines.
- Individuals that regularly participate in high-intensity physical activity, as determined by either self-report or analysis of the Past Year Total Physical Activity Questionnaire (PYTPAQ)
Exclusion
Key Trial Info
Start Date :
December 12 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 28 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00266500
Start Date
December 12 2005
End Date
October 28 2014
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892