ObesityNCT00266500
Body Heat Content and Dissipation in Obese and Normal Weight Adults
An observational study of Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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 of body heat may affect energy expenditure, and therefore, body weight. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2005to 28 Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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 of body heat may affect energy expenditure, and therefore, body weight. This study will explore the relationship between obesity and heat in humans.
Healthy people 18 years of age and older who are of normal weight or who are obese and who are not taking medications for obesity-related medical conditions may be eligible for this study. Candidates must have a body mass index (BMI) between 18 and 25 kg/m2 for normal weight subjects or a BMI greater than 30 kg/m2 for obese subjects. All candidates must weigh less than 300 pounds. Women must have a normal menstrual cycle or be postmenopausal.
Read more
Participants undergo the following procedures in a single day on an outpatient basis:
- Medical history, physical examination, blood and urine tests and electrocardiogram.
- DEXA and MRI scans of the trunk and limbs to measure the amounts of muscle, bone and fat in the body. For the DEXA scan, the subject lies on a table while a very small dose of x-rays is passed through the body. For the MRI, the subject lies on a table that is moved into a steel cylinder. A magnetic field and radio waves produce images that are used to measure fat in the trunk of the body, thighs, and arms.
- Infrared photography of hands, front of thigh, and abdomen. A special camera is used to measure the heat leaving the body.
- Bicycle exercise test. The subject exercises on a stationary bicycle while the heart rate, heart rhythm, blood pressure and oxygen consumption are measured. The pedal resistance is increased gradually until the subject can no longer exercise and then the resistance is gradually decreased for cool-down.
Participants who qualify for the second part of the study undergo the following procedures during a 5-day in-hospital stay:
- Temperature measurements. Body temperature is measured in the ear canal. Skin temperature is measured with small round adhesive temperature-sensing patches placed on the abdomen and limbs for up to 5 days.
- Measurement of body radiowaves. A remote sensing device is used to measure microwaves that are naturally released from the body.
- Infrared photography of hands, front of thigh and abdomen is done several times during the study.
- Application of mild coolness to hands, thigh and abdomen. The subject's hand is exposed to mild coolness first by immersion in cool water, then by a cool-water spray, then by a cooled pad placed on the hand, and finally, with a device applied to the hand that cools and has a gentle vacuum. The abdomen and thigh are similarly exposed. During each test, an infrared camera records how heat is released by the body.
- Temperature effects of a "meal." The subject drinks lemon-flavored sugar water to measure the body's response.
- Bicycle exercise test. The subject exercises on three different occasions. During or after some of the tests, mild cooling is applied to the abdomen, front of the thigh, or hands.
- Measurement of exhaled air (indirect calorimetry). The subject wears a hood that collects and analyzes exhaled air for 15- to 30-minute periods.
- Photography and videotaping. The subject is photographed and videotaped. The images do not include views of any private parts, and the subject's identity is protected.
Read the 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 deficient dissipation of heat can contribute to human obesity, or if obesity induces deficits in heat dissipation, and the relationship between obesity and heat in humans is largely unexplored.
We propose to study obese (BMI greater than or equal to 30 kg/m(2)) and normal weight (BMI less than or equal to 25 kg/m(2)) adults to determine possible obesity-related differences in: 1) regional body temperature heterogeneity (i.e., presence of localized areas of heat retention), 2) the extent to which locally retained heat may be co-localized with deep fat depots, 3) the effectiveness of specific body loci (e.g., the distal extremities) as dissipaters of heat, and 4) the ability of approaches that alter heat dissipation to modify deep-body temperature heterogeneity.
It is hoped that the results of this study will provide preliminary evidence for future studies that attempt to facilitate weight loss in obese subjects through effective, guided applications of heat management.
- Conditions
- Obesity
- Keywords
- Adipose Tissue, Weight Gain, Overweight, Thermogenesis, Deep Body Temperature, Adult, Exercise
- Medical subject headings
- Obesity, Weight Gain, Overweight, Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study start12 Dec 2005
- Study completion28 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266500
- Sponsor's protocol ID
- 060038
- Other IDs
- 06-CH-0038
- Status last verified
- 28 Oct 2014
- First submitted
- 16 Dec 2005
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
PubMed 12365955Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.
PubMed 9813653Finkelstein EA, Ruhm CJ, Kosa KM. Economic causes and consequences of obesity. Annu Rev Public Health. 2005;26:239-57. doi: 10.1146/annurev.publhealth.26.021304.144628.
PubMed 15760288Heikens MJ, Gorbach AM, Eden HS, Savastano DM, Chen KY, Skarulis MC, Yanovski JA. Core body temperature in obesity. Am J Clin Nutr. 2011 May;93(5):963-7. doi: 10.3945/ajcn.110.006270. Epub 2011 Mar 2.
PubMed 21367952Savastano DM, Gorbach AM, Eden HS, Brady SM, Reynolds JC, Yanovski JA. Adiposity and human regional body temperature. Am J Clin Nutr. 2009 Nov;90(5):1124-31. doi: 10.3945/ajcn.2009.27567. Epub 2009 Sep 9.
PubMed 19740972
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Heat Content and Dissipation in Obese and Normal Weight Adults
- ClinicalTrials.gov ID
- NCT00266500
- Acronym / sponsor ID
- 060038
- Conditions
- Obesity
- Keywords
- Adipose Tissue, Weight Gain, Overweight, Thermogenesis, Deep Body Temperature, Adult, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 12 Dec 2005
- Study completion
- 28 Oct 2014
- First posted
- 16 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of body heat may affect energy expenditure, and therefore, body weight. This study will explore the relationship between obesity and heat in humans.
Healthy people 18 years of age and older who are of normal weight or who are obese and who are not taking medications for obesity-related medical conditions may be eligible for this study. Candidates must have a body mass index (BMI) between 18 and 25 kg/m2 for normal weight subjects or a BMI greater than 30 kg/m2 for obese subjects. All candidates must weigh less than 300 pounds. Women must have a normal menstrual cycle or be postmenopausal.
Participants undergo the following procedures in a single day on an outpatient basis:
- Medical history, physical examination, blood and urine tests and electrocardiogram.
- DEXA and MRI scans of the trunk and limbs to measure the amounts of muscle, bone and fat in the body. For the DEXA scan, the subject lies on a table while a very small dose of x-rays is passed through the body. For the MRI, the subject lies on a table that is moved into a steel cylinder. A magnetic field and radio waves produce images that are used to measure fat in the trunk of the body, thighs, and arms.
- Infrared photography of hands, front of thigh, and abdomen. A special camera is used to measure the heat leaving the body.
- Bicycle exercise test. The subject exercises on a stationary bicycle while the heart rate, heart rhythm, blood pressure and oxygen consumption are measured. The pedal resistance is increased gradually until the subject can no longer exercise and then the resistance is gradually decreased for cool-down.
Participants who qualify for the second part of the study undergo the following procedures during a 5-day in-hospital stay:
- Temperature measurements. Body temperature is measured in the ear canal. Skin temperature is measured with small round adhesive temperature-sensing patches placed on the abdomen and limbs for up to 5 days.
- Measurement of body radiowaves. A remote sensing device is used to measure microwaves that are naturally released from the body.
- Infrared photography of hands, front of thigh and abdomen is done several times during the study.
- Application of mild coolness to hands, thigh and abdomen. The subject's hand is exposed to mild coolness first by immersion in cool water, then by a cool-water spray, then by a cooled pad placed on the hand, and finally, with a device applied to the hand that cools and has a gentle vacuum. The abdomen and thigh are similarly exposed. During each test, an infrared camera records how heat is released by the body.
- Temperature effects of a "meal." The subject drinks lemon-flavored sugar water to measure the body's response.
- Bicycle exercise test. The subject exercises on three different occasions. During or after some of the tests, mild cooling is applied to the abdomen, front of the thigh, or hands.
- Measurement of exhaled air (indirect calorimetry). The subject wears a hood that collects and analyzes exhaled air for 15- to 30-minute periods.
- Photography and videotaping. The subject is photographed and videotaped. The images do not include views of any private parts, and the subject's identity is protected.
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 deficient dissipation of heat can contribute to human obesity, or if obesity induces deficits in heat dissipation, and the relationship between obesity and heat in humans is largely unexplored.
We propose to study obese (BMI greater than or equal to 30 kg/m(2)) and normal weight (BMI less than or equal to 25 kg/m(2)) adults to determine possible obesity-related differences in: 1) regional body temperature heterogeneity (i.e., presence of localized areas of heat retention), 2) the extent to which locally retained heat may be co-localized with deep fat depots, 3) the effectiveness of specific body loci (e.g., the distal extremities) as dissipaters of heat, and 4) the ability of approaches that alter heat dissipation to modify deep-body temperature heterogeneity.
It is hoped that the results of this study will provide preliminary evidence for future studies that attempt to facilitate weight loss in obese subjects through effective, guided applications of heat management.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 12365955Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
- Background: PubMed 9813653Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.
- Background: PubMed 15760288Finkelstein EA, Ruhm CJ, Kosa KM. Economic causes and consequences of obesity. Annu Rev Public Health. 2005;26:239-57. doi: 10.1146/annurev.publhealth.26.021304.144628.
- Derived from this study: PubMed 21367952Heikens MJ, Gorbach AM, Eden HS, Savastano DM, Chen KY, Skarulis MC, Yanovski JA. Core body temperature in obesity. Am J Clin Nutr. 2011 May;93(5):963-7. doi: 10.3945/ajcn.110.006270. Epub 2011 Mar 2.
- Derived from this study: PubMed 19740972Savastano DM, Gorbach AM, Eden HS, Brady SM, Reynolds JC, Yanovski JA. Adiposity and human regional body temperature. Am J Clin Nutr. 2009 Nov;90(5):1124-31. doi: 10.3945/ajcn.2009.27567. Epub 2009 Sep 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00266500, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.