Healthy VolunteersNCT00312715
Thyroid and Fat Tissue Metabolism
An observational study of Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will use a technique called microperfusion to examine how thyroid hormones are involved in fat metabolism. The thyroid gland produces two kinds of hormones: T3 and T4. Some of the T4 is changed to T3 in various organs after leaving the thyroid. The T3 stimulates the body to burn fat. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2006to 8 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years, male or female.
- Written informed consent.
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 [17] or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 30 Kg/m(2).
- Diabetes mellitus (serum glucose greater than or equal to 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 15Show fewer
- Liver disease or ALT serum level greater than two fold the upper laboratory reference limit.
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (Cockcroft method).
- 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.
- Allergy to ethanol, levothyroxine, liothyronine, isoproterenol, lidocaine.
- Pregnancy/breastfeeding.
- Current smoker
- All subjects will be fully informed of the aim, nature, and risks of the study prior to giving written informed consent.
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 Hormone-Induced Lipolysis: An In Vivo Microdialysis Study
This study will use a technique called microperfusion to examine how thyroid hormones are involved in fat metabolism. The thyroid gland produces two kinds of hormones: T3 and T4. Some of the T4 is changed to T3 in various organs after leaving the thyroid. The T3 stimulates the body to burn fat. People have different rates at which they can change T4 to T3, and this may lead to differences in body fat among different people.
Microperfusion is based on the exchange of substances across tiny holes of a small plastic tube called a "probe," which is inserted after numbing the skin over a fat pad. Through these openings, the fat pad is continuously rinsed with small amounts of fluid, and an exchange of substances occurs. The fluid drips from the other opening of the probe and is collected in a vial. Small amounts of study drugs are infused and the amount of substances released by the fat pad in response to them are measured.
Read more
Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination and blood tests.
Participants undergo microperfusion. A needle is placed in an arm vein for collecting blood samples before and at the end of the experiment for measuring thyroid hormones and other substances in the blood. The skin over the fat pad next to the umbilicus (navel) is numbed and two microperfusion probes are inserted. A salt water solution is infused into the fat pad for one hour and the substances in the fluid are measured as the fluid leaves the fat pad. After 1 hour isoproterenol, a drug that aids in energy production by fat, is added to help determine the level of fat metabolism. After an additional hour small amounts of thyroid hormone are added to the fluid and samples are collected as they leave the body. Two catheters are inserted during each experiment. Small volumes of sterile fluid are circulated continuously in the tubing and samples are collected at regular intervals.
Read the detailed description
This study will examine how two thyroid preparations, levothyroxine (T4) and liothyronine (T3), affect subcutaneous adipose tissue in normal subjects. Thyroid hormone plays an important role in the maintenance of energy metabolism. Specifically, hyperthyroidism is associated with weight loss via an increase in metabolic rate and lipolysis. While this phenomenon has been studied in vitro quite extensively, very little information is available on the local action of thyroid hormone on adipose tissue in vivo and, in particular, at the present no information is available on the role of peripheral conversion of thyroid hormone in subcutaneous adipose tissue. We thus propose to study the local action of thyroid hormones on adipose tissue using microdialysis, a minimally invasive technique that allows the serial determination of components of the extracellular fluid. The measurement of glycerol after correction for changes in blood flow will be used to evaluate the effects of the thyroid hormones on local lipolysis.
Healthy volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Subjects with hyperlipidemia, impaired glucose tolerance or diabetes and thyroid disease are not eligible for the participation in this study. Qualifying study participants undergo subcutaneous fat tissue microdialysis to assess the effects of T3 and T4 on the activity of fat tissue. The medications isoproterenol and T3 or T4 are injected in fat tissue under the skin of the abdomen, and fluid samples are collected from the area over a 6-12 hour period using the same small needle. Glycerol is then measured to study how the thyroid hormones affect fat metabolism. During this procedure a 10% glucose solution is infused through the catheter in the arm to limit lipolysis due to fasting. Four different sets of experiments are performed with different thyroid hormone doses and/or durations.
These experiments will provide new information on the role of thyroid hormone in the regulation of adipose tissue metabolism and will help in identifying new treatments for the management of obesity.
- Conditions
- Healthy Volunteers
- Keywords
- Deiodinase, Levothyroxine, Liothyronine, Lipid Metabolism, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study start3 Apr 2006
- Study completion8 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Francesco S Celi, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312715
- Sponsor's protocol ID
- 060133
- Other IDs
- 06-DK-0133
- Status last verified
- 8 Jul 2014
- First submitted
- 8 Apr 2006
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Elks ML, Manganiello VC. Effects of thyroid hormone on regulation of lipolysis and adenosine 3',5'-monophosphate metabolism in 3T3-L1 adipocytes. Endocrinology. 1985 Sep;117(3):947-53. doi: 10.1210/endo-117-3-947.
PubMed 2410243Germack R, Starzec A, Perret GY. Regulation of beta 1- and beta 3-adrenergic agonist-stimulated lipolytic response in hyperthyroid and hypothyroid rat white adipocytes. Br J Pharmacol. 2000 Feb;129(3):448-56. doi: 10.1038/sj.bjp.0703008.
PubMed 10711342Mentuccia D, Proietti-Pannunzi L, Tanner K, Bacci V, Pollin TI, Poehlman ET, Shuldiner AR, Celi FS. Association between a novel variant of the human type 2 deiodinase gene Thr92Ala and insulin resistance: evidence of interaction with the Trp64Arg variant of the beta-3-adrenergic receptor. Diabetes. 2002 Mar;51(3):880-3. doi: 10.2337/diabetes.51.3.880.
PubMed 11872697
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Hormone-Induced Lipolysis: An In Vivo Microdialysis Study
- ClinicalTrials.gov ID
- NCT00312715
- Acronym / sponsor ID
- 060133
- Conditions
- Healthy Volunteers
- Keywords
- Deiodinase, Levothyroxine, Liothyronine, Lipid Metabolism, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 3 Apr 2006
- Study completion
- 8 Jul 2014
- First posted
- 10 Apr 2006 (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 use a technique called microperfusion to examine how thyroid hormones are involved in fat metabolism. The thyroid gland produces two kinds of hormones: T3 and T4. Some of the T4 is changed to T3 in various organs after leaving the thyroid. The T3 stimulates the body to burn fat. People have different rates at which they can change T4 to T3, and this may lead to differences in body fat among different people.
Microperfusion is based on the exchange of substances across tiny holes of a small plastic tube called a "probe," which is inserted after numbing the skin over a fat pad. Through these openings, the fat pad is continuously rinsed with small amounts of fluid, and an exchange of substances occurs. The fluid drips from the other opening of the probe and is collected in a vial. Small amounts of study drugs are infused and the amount of substances released by the fat pad in response to them are measured.
Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination and blood tests.
Participants undergo microperfusion. A needle is placed in an arm vein for collecting blood samples before and at the end of the experiment for measuring thyroid hormones and other substances in the blood. The skin over the fat pad next to the umbilicus (navel) is numbed and two microperfusion probes are inserted. A salt water solution is infused into the fat pad for one hour and the substances in the fluid are measured as the fluid leaves the fat pad. After 1 hour isoproterenol, a drug that aids in energy production by fat, is added to help determine the level of fat metabolism. After an additional hour small amounts of thyroid hormone are added to the fluid and samples are collected as they leave the body. Two catheters are inserted during each experiment. Small volumes of sterile fluid are circulated continuously in the tubing and samples are collected at regular intervals.
Detailed description
This study will examine how two thyroid preparations, levothyroxine (T4) and liothyronine (T3), affect subcutaneous adipose tissue in normal subjects. Thyroid hormone plays an important role in the maintenance of energy metabolism. Specifically, hyperthyroidism is associated with weight loss via an increase in metabolic rate and lipolysis. While this phenomenon has been studied in vitro quite extensively, very little information is available on the local action of thyroid hormone on adipose tissue in vivo and, in particular, at the present no information is available on the role of peripheral conversion of thyroid hormone in subcutaneous adipose tissue. We thus propose to study the local action of thyroid hormones on adipose tissue using microdialysis, a minimally invasive technique that allows the serial determination of components of the extracellular fluid. The measurement of glycerol after correction for changes in blood flow will be used to evaluate the effects of the thyroid hormones on local lipolysis.
Healthy volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Subjects with hyperlipidemia, impaired glucose tolerance or diabetes and thyroid disease are not eligible for the participation in this study. Qualifying study participants undergo subcutaneous fat tissue microdialysis to assess the effects of T3 and T4 on the activity of fat tissue. The medications isoproterenol and T3 or T4 are injected in fat tissue under the skin of the abdomen, and fluid samples are collected from the area over a 6-12 hour period using the same small needle. Glycerol is then measured to study how the thyroid hormones affect fat metabolism. During this procedure a 10% glucose solution is infused through the catheter in the arm to limit lipolysis due to fasting. Four different sets of experiments are performed with different thyroid hormone doses and/or durations.
These experiments will provide new information on the role of thyroid hormone in the regulation of adipose tissue metabolism and will help in identifying new treatments for the management of obesity.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years, male or female.
- Written informed consent.
Key exclusion criteria (15 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 [17] or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 30 Kg/m(2).
- Diabetes mellitus (serum glucose greater than or equal to 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.
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 6 Oct 2017.
- Background: PubMed 2410243Elks ML, Manganiello VC. Effects of thyroid hormone on regulation of lipolysis and adenosine 3',5'-monophosphate metabolism in 3T3-L1 adipocytes. Endocrinology. 1985 Sep;117(3):947-53. doi: 10.1210/endo-117-3-947.
- Background: PubMed 10711342Germack R, Starzec A, Perret GY. Regulation of beta 1- and beta 3-adrenergic agonist-stimulated lipolytic response in hyperthyroid and hypothyroid rat white adipocytes. Br J Pharmacol. 2000 Feb;129(3):448-56. doi: 10.1038/sj.bjp.0703008.
- Background: PubMed 11872697Mentuccia D, Proietti-Pannunzi L, Tanner K, Bacci V, Pollin TI, Poehlman ET, Shuldiner AR, Celi FS. Association between a novel variant of the human type 2 deiodinase gene Thr92Ala and insulin resistance: evidence of interaction with the Trp64Arg variant of the beta-3-adrenergic receptor. Diabetes. 2002 Mar;51(3):880-3. doi: 10.2337/diabetes.51.3.880.
Related trials for Healthy Volunteers
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Enrolling by invitation
Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods
Healthy
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.
Francesco S Celi, M.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?
An observational study of Healthy Volunteers, 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 2 inclusion and 15 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 6 Oct 2017. 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 NCT00312715, which also lists 3 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 6 Oct 2017.