ObesityNCT00521729
Metabolism and Thyroid Hormone Changes During Exposure to Cold Temperatures
A study testing Exposure to Cold Temperature in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exposure to Cold Temperature
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2007to 26 Jun 2018
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age greater than or equal to18
- Written informed consent
- (for SDH study only: <60 years old, documented SDH mutation without clinical evidence of pheochromocytoma or biochemical evidence of excess of catecholamines. The assessment will be performed within the context of the 00-CH-0093 protocol, P.I. Karel Pacak).
Who cannot join
- Hypo- or hyper-thyroid (history or TSH greater than 5.0 and less than 0.4 miU/L)
- Blood pressure greater than 140/90 mmHg or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 35 Kg/m(2)
- Diabetes mellitus (fasting serum glucose X greater than 126 mg/dL)
- Hypercholesterolemia (serum levels greater than or equal to 240 mg/dL), hypertriglyceridemia (plasma levels greater than or equal to 220 mg/dL) and/or use of antilipemic therapy
Show all 18Show fewer
- Liver disease or ALT serum level greater than two fold the upper laboratory reference limit
- Iron deficiency (Ferritin less than 40 ng/mL males, and less than 20 ng/mL females)
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (MDRD equation)
- Claustrophobia
- History of illicit drug or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE greater than 3)
- Psychiatric conditions or behavior that would be incompatible with safe and successful participation in this study
- Current use of medications/dietary supplements/alternative therapies known to alter thyroid function
- Current use of antiplatelet or anticoagulants
- Allergy to lidocaine
- Pregnancy/breastfeeding/hormonal contraception and childbirth within the last 24 months
- Perimenopausal (as self-described within two years from onset of amenorrhea or current complaints of hot flashes)
- Current smoker or user of tobacco products
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
Official title: Thyroid Hormones Homeostasis and Energy Metabolism Changes During Exposure to Cold Temperature in Humans
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:
Read more
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:
- Continuous heart rate monitor: Subjects wear an EKG monitor to analyze heart rate variability.
- Spontaneous movements: Subjects wear portable accelerometers at the hip and wrist to measure spontaneous physical movements.
- Continuous temperature monitor: Subjects swallow a small capsule that transmits internal body temperature via miniature, wireless sensors. Adhesive patches placed on the skin monitor external body temperature.
- Blood and urine collections: Subjects collect all of their urine during the 12 hours they are in the metabolic room. Blood samples are taken at specified intervals through a catheter that has been placed in a vein.
- Microdialysis: A small needle is placed into fat tissue just under the skin on the abdomen. A solution containing a minimal amount of ethanol is infused and samples of fluid are collected every 20 minutes as it leaves the fat pad. This helps determine the metabolism level. This procedure starts 30 minutes before entering the metabolic room and continues until the subject leaves the room.
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.
Read the detailed description
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.
A total of 230 lean and overweight volunteers who are 18 years of age or older, following a two-day period of standardized diet, will be randomized to either a normal (75 (Infinite)F/24 (Infinite)C) or low-temperature (64 (Infinite)F/18 (Infinite)C) 12- or 24-hour stay in a temperature-controlled metabolic chamber. A standard meal will be provided after six hours of recording in studies performed during the daytime. After a two-day resting period the test will be then repeated at the second temperature. In order to visualize and quantify the metabolic activity of brown adipose tissue (BAT), twenty five lean study volunteers younger than 60 will be asked to undergo a 18-fluoro-deoxy-glucose PET-scan after each of the two 12-hour overnight stays in the metabolic chamber. In order to determine the impact of mitochondrial function on cold-stimulated BAT activity, a sub-group of volunteers who carry a mutation in the mitochondrial genes, succinate dehydrogenases, and age- and gender-matched control subjects, will undergo PET/CT scanning at the end of a 24-hour stay in the metabolic chamber at 18 (Infinite)C and 24 (Infinite)C.
The following parameters will be recorded and analyzed: Changes in skin and core temperature, heart rate and its variability, energy expenditure, changes in circulating thyroid hormones, ACTH, cortisol, and catecholamines. Changes in glucose uptake in relation to changes in energy expenditure will be measured by PET-scan.
The adipose tissue metabolism will be analyzed by microdialysis and study volunteers will be asked to undergo subcutaneous adipose tissue needle biopsy.
The data gathered from this study will provide a comprehensive insight into the mechanism(s) regulating the energy metabolism in response to mild cold. The results obtained from the proposed experiments might lead to the characterization of a population of subjects who are requiring excessive energy expenditure to prevent hypothermia upon cold exposure. Thus, we hypothesize that in a subset of subjects an exposure to mild cold will produce a negative energy balance ultimately facilitating weight loss.
- Conditions
- Obesity
- Being tested
- Exposure to Cold Temperature
- Keywords
- Thyroid, Thermoregulation, Catecholamines, Energy Expenditure, Obesity, Healthy Volunteer, HV
- Medical subject headings
- Obesity, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to Cold TemperatureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in energy expenditure and in thyroid hormone levels
Secondary outcomes (1)
Changes in spontaneous physical activity and in thermic effect of food
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study start24 Aug 2007
- Primary completion12 Jan 2015
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Kong Y Chen, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521729
- Sponsor's protocol ID
- 070202
- Other IDs
- 07-DK-0202
- Status last verified
- 26 Jun 2018
- First submitted
- 25 Aug 2007
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Hill JO. Understanding and addressing the epidemic of obesity: an energy balance perspective. Endocr Rev. 2006 Dec;27(7):750-61. doi: 10.1210/er.2006-0032. Epub 2006 Nov 22.
PubMed 17122359Rosen ED, Spiegelman BM. Adipocytes as regulators of energy balance and glucose homeostasis. Nature. 2006 Dec 14;444(7121):847-53. doi: 10.1038/nature05483.
PubMed 17167472Katzmarzyk PT, Leonard WR. Climatic influences on human body size and proportions: ecological adaptations and secular trends. Am J Phys Anthropol. 1998 Aug;106(4):483-503. doi: 10.1002/(SICI)1096-8644(199808)106:43.0.CO;2-K.
PubMed 9712477Celi FS, Brychta RJ, Linderman JD, Butler PW, Alberobello AT, Smith S, Courville AB, Lai EW, Costello R, Skarulis MC, Csako G, Remaley A, Pacak K, Chen KY. Minimal changes in environmental temperature result in a significant increase in energy expenditure and changes in the hormonal homeostasis in healthy adults. Eur J Endocrinol. 2010 Dec;163(6):863-72. doi: 10.1530/EJE-10-0627. Epub 2010 Sep 8.
PubMed 20826525
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Hormones Homeostasis and Energy Metabolism Changes During Exposure to Cold Temperature in Humans
- ClinicalTrials.gov ID
- NCT00521729
- Acronym / sponsor ID
- 070202
- Conditions
- Obesity
- Keywords
- Thyroid, Thermoregulation, Catecholamines, Energy Expenditure, Obesity, Healthy Volunteer, HV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 24 Aug 2007
- Primary completion
- 12 Jan 2015 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 28 Aug 2007 (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 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:
- Continuous heart rate monitor: Subjects wear an EKG monitor to analyze heart rate variability.
- Spontaneous movements: Subjects wear portable accelerometers at the hip and wrist to measure spontaneous physical movements.
- Continuous temperature monitor: Subjects swallow a small capsule that transmits internal body temperature via miniature, wireless sensors. Adhesive patches placed on the skin monitor external body temperature.
- Blood and urine collections: Subjects collect all of their urine during the 12 hours they are in the metabolic room. Blood samples are taken at specified intervals through a catheter that has been placed in a vein.
- Microdialysis: A small needle is placed into fat tissue just under the skin on the abdomen. A solution containing a minimal amount of ethanol is infused and samples of fluid are collected every 20 minutes as it leaves the fat pad. This helps determine the metabolism level. This procedure starts 30 minutes before entering the metabolic room and continues until the subject leaves the room.
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.
Detailed description
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.
A total of 230 lean and overweight volunteers who are 18 years of age or older, following a two-day period of standardized diet, will be randomized to either a normal (75 (Infinite)F/24 (Infinite)C) or low-temperature (64 (Infinite)F/18 (Infinite)C) 12- or 24-hour stay in a temperature-controlled metabolic chamber. A standard meal will be provided after six hours of recording in studies performed during the daytime. After a two-day resting period the test will be then repeated at the second temperature. In order to visualize and quantify the metabolic activity of brown adipose tissue (BAT), twenty five lean study volunteers younger than 60 will be asked to undergo a 18-fluoro-deoxy-glucose PET-scan after each of the two 12-hour overnight stays in the metabolic chamber. In order to determine the impact of mitochondrial function on cold-stimulated BAT activity, a sub-group of volunteers who carry a mutation in the mitochondrial genes, succinate dehydrogenases, and age- and gender-matched control subjects, will undergo PET/CT scanning at the end of a 24-hour stay in the metabolic chamber at 18 (Infinite)C and 24 (Infinite)C.
The following parameters will be recorded and analyzed: Changes in skin and core temperature, heart rate and its variability, energy expenditure, changes in circulating thyroid hormones, ACTH, cortisol, and catecholamines. Changes in glucose uptake in relation to changes in energy expenditure will be measured by PET-scan.
The adipose tissue metabolism will be analyzed by microdialysis and study volunteers will be asked to undergo subcutaneous adipose tissue needle biopsy.
The data gathered from this study will provide a comprehensive insight into the mechanism(s) regulating the energy metabolism in response to mild cold. The results obtained from the proposed experiments might lead to the characterization of a population of subjects who are requiring excessive energy expenditure to prevent hypothermia upon cold exposure. Thus, we hypothesize that in a subset of subjects an exposure to mild cold will produce a negative energy balance ultimately facilitating weight loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age greater than or equal to18
- Written informed consent
- (for SDH study only: <60 years old, documented SDH mutation without clinical evidence of pheochromocytoma or biochemical evidence of excess of catecholamines. The assessment will be performed within the context of the 00-CH-0093 protocol, P.I. Karel Pacak).
Key exclusion criteria (18 listed)
- Hypo- or hyper-thyroid (history or TSH greater than 5.0 and less than 0.4 miU/L)
- Blood pressure greater than 140/90 mmHg or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 35 Kg/m(2)
- Diabetes mellitus (fasting serum glucose X greater than 126 mg/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to Cold Temperature | Procedure or surgery | – |
Primary outcome
Changes in energy expenditure and in thyroid hormone levels
1 secondary outcome
Changes in spontaneous physical activity and in thermic effect of food
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 16 Dec 2019.
- Background: PubMed 17122359Hill JO. Understanding and addressing the epidemic of obesity: an energy balance perspective. Endocr Rev. 2006 Dec;27(7):750-61. doi: 10.1210/er.2006-0032. Epub 2006 Nov 22.
- Background: PubMed 17167472Rosen ED, Spiegelman BM. Adipocytes as regulators of energy balance and glucose homeostasis. Nature. 2006 Dec 14;444(7121):847-53. doi: 10.1038/nature05483.
- Background: PubMed 9712477Katzmarzyk PT, Leonard WR. Climatic influences on human body size and proportions: ecological adaptations and secular trends. Am J Phys Anthropol. 1998 Aug;106(4):483-503. doi: 10.1002/(SICI)1096-8644(199808)106:43.0.CO;2-K.
- Derived from this study: PubMed 20826525Celi FS, Brychta RJ, Linderman JD, Butler PW, Alberobello AT, Smith S, Courville AB, Lai EW, Costello R, Skarulis MC, Csako G, Remaley A, Pacak K, Chen KY. Minimal changes in environmental temperature result in a significant increase in energy expenditure and changes in the hormonal homeostasis in healthy adults. Eur J Endocrinol. 2010 Dec;163(6):863-72. doi: 10.1530/EJE-10-0627. Epub 2010 Sep 8.
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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.
Kong Y Chen, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to Cold Temperature in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 3 inclusion and 18 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 16 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.
What does the primary outcome measure?
Changes in energy expenditure and in thyroid hormone levels. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521729, which also lists 4 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 16 Dec 2019.