HypothyroidismNCT02499471
Brown Adipose Tissue Activity and Thyroid Hormone
A study testing Levothyroxine therapy (137.75 ± 23.75 μg/day) in people with Hypothyroidism and Hyperthyroidism, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: During the last decades, research in possible therapies for existing obesity and developmental factors causing obesity has explosively increased. Recently renewed interest aroused for a tissue playing a possible role in both development and therapy for obesity: brown adipose tissue (BAT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypothyroidism, Hyperthyroidism, Obesity
- What is being tested?
- Levothyroxine therapy (137.75 ± 23.75 μg/day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Jul 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or postmenopausal females undergoing a total thyroidectomy for well-differentiated thyroid carcinoma
- Age 18-65 years
- Stable physical activity levels for at least six months
- Note: In case of use of anticoagulation, the dose will be adjusted according to plasma thyroid hormone values.
Who cannot join
- Psychologically unstable subjects (as judged by the treating medical specialist)
- Subjects with mental retardation (as judged by the treating medical specialist)
- Subjects with severe behavior disorders (as judged by the treating medical specialist)
- Pregnant subjects
- The use of the following medication is an exclusion criterium; ß-blockers
- Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
- Abuse of drugs and/or alcohol
- Severe diabetes which requires application of insulin or patients with diabetes-related complications
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: During the last decades, research in possible therapies for existing obesity and developmental factors causing obesity has explosively increased. Recently renewed interest aroused for a tissue playing a possible role in both development and therapy for obesity: brown adipose tissue (BAT).
To define the relation between BAT and thyroid hormone, the investigators set up the following research protocol. In this protocol BAT activity will be determined in subjects that underwent thyroidectomy for well-differentiated thyroid carcinoma.
Read more
Objective: To study the effect of thyroid hormone and thyroid-stimulating hormone on brown adipose tissue activity.
Study design: Determine BAT activity after thyroidectomy in well-differentiated thyroid carcinoma patients.
Study population: Patients that underwent thyroidectomy for well-differentiated thyroid carcinoma, male and female, aged 18-65 years.
Intervention: FDG-PET-CT-imaging ([18F]fluorodeoxyglucose positron-emission-tomography computed-tomography) of BAT activity will be performed under cold stimulation twice.
For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will take place in a euthyroid state 4 months after the start of thyroid hormone treatment.
For patients receiving recombinant-thyroid-stimulating-hormone injections, the first occasion will be shortly after the injection in a state of high thyroid-stimulating hormone levels. The second measurement will be in a euthyroid state 4 months after the injection.
Main study parameters/endpoints: The main endpoint of this study is the effect of thyroid hormone and thyroid-stimulating hormone on BAT activity in kBq (kilobecquerel) and SUV (standard uptake value). Secondary endpoints are the effects of thyroid hormone and thyroid-stimulating hormone on energy metabolism, body core temperature, skin surface temperatures and skin perfusion.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The absorbed radiation dose from the FDG PET-CT scan after administration of 74 MBq (megabecquerel) of 18F-FDG is 2.8 mSv (miliSievert).
- Conditions
- Hypothyroidism, Hyperthyroidism, Obesity
- Being tested
- Levothyroxine therapy (137.75 ± 23.75 μg/day)
- Medical subject headings
- Hypothyroidism, Hyperthyroidism, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine therapy (137.75 ± 23.75 μg/day)Other
This study was a longitudinal study in an academic center, with a follow-up period of 6 months. Ten patients with well-differentiated thyroid carcinoma eligible for surgical treatment and subsequent radioactive iodine ablation therapy were studied in a hypothyroid state after thyroidectomy and in a subclinical hyperthyroid state (TSH-suppression according to standard treatment protocol).
| Study group | Role | What they receive |
|---|---|---|
| Before levothyroxine therapy 137.75 μg | Other | 18F-FDG PET CT scan after mild cold exposure 6.8 ± 2.8 weeks after thyroidectomy, when plasma free T4-levels were at the minimum, before daily levothyroxine therapy 137.75 ± 25.75 μg. Receives: Other: Levothyroxine therapy (137.75 ± 23.75 μg/day) |
| After levothyroxine therapy 137.75 μg | Other | 18F-FDG PET CT scan after mild cold exposure four to six months after the initial measurements, after daily levothyroxine therapy 137.75 μg (fT4 levels 23.1 ± 3.9 pmol/L, TSH 0.5 ± 0.6 mU/L) Receives: Other: Levothyroxine therapy (137.75 ± 23.75 μg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold-induced brown adipose tissue activity
Measured with 18FDG PET/CT scan after personalised cooling protocol
Measured: 1 day
Secondary outcomes (4)
Energy expenditure
Energy expenditure measured with ventilated hood system
Measured: 1 day
Body core temperature
Body core temperature measured with CorTemp telemetric pill
Measured: 1 day
Skin temperatures
Skin temperatures measured with iButton wireless dataloggers at 14 ISO-defined positions on the skin
Measured: 1 day
Skin perfusion
Skin perfusion measured with laser-doppler flowmetry on hand and forearm
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter van Marken Lichtenbelt, Professor, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499471
- Sponsor's protocol ID
- NL 39146.068.11
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
PubMed 15010446van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
PubMed 19357405Virtanen KA, Lidell ME, Orava J, Heglind M, Westergren R, Niemi T, Taittonen M, Laine J, Savisto NJ, Enerback S, Nuutila P. Functional brown adipose tissue in healthy adults. N Engl J Med. 2009 Apr 9;360(15):1518-25. doi: 10.1056/NEJMoa0808949.
PubMed 19357407Cannon B, Nedergaard J. Brown adipose tissue: function and physiological significance. Physiol Rev. 2004 Jan;84(1):277-359. doi: 10.1152/physrev.00015.2003.
PubMed 14715917Saito M, Okamatsu-Ogura Y, Matsushita M, Watanabe K, Yoneshiro T, Nio-Kobayashi J, Iwanaga T, Miyagawa M, Kameya T, Nakada K, Kawai Y, Tsujisaki M. High incidence of metabolically active brown adipose tissue in healthy adult humans: effects of cold exposure and adiposity. Diabetes. 2009 Jul;58(7):1526-31. doi: 10.2337/db09-0530. Epub 2009 Apr 28.
PubMed 19401428Orava J, Nuutila P, Lidell ME, Oikonen V, Noponen T, Viljanen T, Scheinin M, Taittonen M, Niemi T, Enerback S, Virtanen KA. Different metabolic responses of human brown adipose tissue to activation by cold and insulin. Cell Metab. 2011 Aug 3;14(2):272-9. doi: 10.1016/j.cmet.2011.06.012.
PubMed 21803297van der Lans AA, Hoeks J, Brans B, Vijgen GH, Visser MG, Vosselman MJ, Hansen J, Jorgensen JA, Wu J, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Cold acclimation recruits human brown fat and increases nonshivering thermogenesis. J Clin Invest. 2013 Aug;123(8):3395-403. doi: 10.1172/JCI68993. Epub 2013 Jul 15.
PubMed 23867626TATA JR, ERNSTER L, LINDBERG O. Control of basal metabolic rate by thyroid hormones and cellular function. Nature. 1962 Mar 17;193:1058-60. doi: 10.1038/1931058a0. No abstract available.
PubMed 13919771Goglia F, Silvestri E, Lanni A. Thyroid hormones and mitochondria. Biosci Rep. 2002 Feb;22(1):17-32. doi: 10.1023/a:1016056905347.
PubMed 12418548Bianco AC, Salvatore D, Gereben B, Berry MJ, Larsen PR. Biochemistry, cellular and molecular biology, and physiological roles of the iodothyronine selenodeiodinases. Endocr Rev. 2002 Feb;23(1):38-89. doi: 10.1210/edrv.23.1.0455.
PubMed 11844744Johannsen DL, Galgani JE, Johannsen NM, Zhang Z, Covington JD, Ravussin E. Effect of short-term thyroxine administration on energy metabolism and mitochondrial efficiency in humans. PLoS One. 2012;7(7):e40837. doi: 10.1371/journal.pone.0040837. Epub 2012 Jul 26.
PubMed 22844412Lee JY, Takahashi N, Yasubuchi M, Kim YI, Hashizaki H, Kim MJ, Sakamoto T, Goto T, Kawada T. Triiodothyronine induces UCP-1 expression and mitochondrial biogenesis in human adipocytes. Am J Physiol Cell Physiol. 2012 Jan 15;302(2):C463-72. doi: 10.1152/ajpcell.00010.2011. Epub 2011 Nov 9.
PubMed 22075692de Jesus LA, Carvalho SD, Ribeiro MO, Schneider M, Kim SW, Harney JW, Larsen PR, Bianco AC. The type 2 iodothyronine deiodinase is essential for adaptive thermogenesis in brown adipose tissue. J Clin Invest. 2001 Nov;108(9):1379-85. doi: 10.1172/JCI13803.
PubMed 11696583Endo T, Kobayashi T. Thyroid-stimulating hormone receptor in brown adipose tissue is involved in the regulation of thermogenesis. Am J Physiol Endocrinol Metab. 2008 Aug;295(2):E514-8. doi: 10.1152/ajpendo.90433.2008. Epub 2008 Jun 17.
PubMed 18559984Lopez M, Varela L, Vazquez MJ, Rodriguez-Cuenca S, Gonzalez CR, Velagapudi VR, Morgan DA, Schoenmakers E, Agassandian K, Lage R, Martinez de Morentin PB, Tovar S, Nogueiras R, Carling D, Lelliott C, Gallego R, Oresic M, Chatterjee K, Saha AK, Rahmouni K, Dieguez C, Vidal-Puig A. Hypothalamic AMPK and fatty acid metabolism mediate thyroid regulation of energy balance. Nat Med. 2010 Sep;16(9):1001-8. doi: 10.1038/nm.2207. Epub 2010 Aug 29.
PubMed 20802499
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Adipose Tissue Activity and Thyroid Hormone
- ClinicalTrials.gov ID
- NCT02499471
- Acronym / sponsor ID
- NL 39146.068.11
- Conditions
- Hypothyroidism, Hyperthyroidism, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Jul 2015 (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.
Rationale: During the last decades, research in possible therapies for existing obesity and developmental factors causing obesity has explosively increased. Recently renewed interest aroused for a tissue playing a possible role in both development and therapy for obesity: brown adipose tissue (BAT).
To define the relation between BAT and thyroid hormone, the investigators set up the following research protocol. In this protocol BAT activity will be determined in subjects that underwent thyroidectomy for well-differentiated thyroid carcinoma.
Objective: To study the effect of thyroid hormone and thyroid-stimulating hormone on brown adipose tissue activity.
Study design: Determine BAT activity after thyroidectomy in well-differentiated thyroid carcinoma patients.
Study population: Patients that underwent thyroidectomy for well-differentiated thyroid carcinoma, male and female, aged 18-65 years.
Intervention: FDG-PET-CT-imaging ([18F]fluorodeoxyglucose positron-emission-tomography computed-tomography) of BAT activity will be performed under cold stimulation twice.
For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will take place in a euthyroid state 4 months after the start of thyroid hormone treatment.
For patients receiving recombinant-thyroid-stimulating-hormone injections, the first occasion will be shortly after the injection in a state of high thyroid-stimulating hormone levels. The second measurement will be in a euthyroid state 4 months after the injection.
Main study parameters/endpoints: The main endpoint of this study is the effect of thyroid hormone and thyroid-stimulating hormone on BAT activity in kBq (kilobecquerel) and SUV (standard uptake value). Secondary endpoints are the effects of thyroid hormone and thyroid-stimulating hormone on energy metabolism, body core temperature, skin surface temperatures and skin perfusion.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The absorbed radiation dose from the FDG PET-CT scan after administration of 74 MBq (megabecquerel) of 18F-FDG is 2.8 mSv (miliSievert).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before levothyroxine therapy 137.75 μg | Other | Other: Levothyroxine therapy (137.75 ± 23.75 μg/day)18F-FDG PET CT scan after mild cold exposure 6.8 ± 2.8 weeks after thyroidectomy, when plasma free T4-levels were at the minimum, before daily levothyroxine therapy 137.75 ± 25.75 μg. |
| After levothyroxine therapy 137.75 μg | Other | Other: Levothyroxine therapy (137.75 ± 23.75 μg/day)18F-FDG PET CT scan after mild cold exposure four to six months after the initial measurements, after daily levothyroxine therapy 137.75 μg (fT4 levels 23.1 ± 3.9 pmol/L, TSH 0.5 ± 0.6 mU/L) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or postmenopausal females undergoing a total thyroidectomy for well-differentiated thyroid carcinoma
- Age 18-65 years
- Stable physical activity levels for at least six months
- Note: In case of use of anticoagulation, the dose will be adjusted according to plasma thyroid hormone values.
Key exclusion criteria (8 listed)
- Psychologically unstable subjects (as judged by the treating medical specialist)
- Subjects with mental retardation (as judged by the treating medical specialist)
- Subjects with severe behavior disorders (as judged by the treating medical specialist)
- Pregnant subjects
- The use of the following medication is an exclusion criterium; ß-blockers
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 |
|---|---|---|
| Levothyroxine therapy (137.75 ± 23.75 μg/day)This study was a longitudinal study in an academic center, with a follow-up period of 6 months. Ten patients with well-differentiated thyroid carcinoma eligible for surgical treatment and subsequent radioactive iodine ablation therapy were studied in a hypothyroid state after thyroidectomy and in a subclinical hyperthyroid state (TSH-suppression according to standard treatment protocol). | Other | After levothyroxine therapy 137.75 μg, Before levothyroxine therapy 137.75 μg |
Primary outcome
Cold-induced brown adipose tissue activity
Time frame: 1 day
Measured with 18FDG PET/CT scan after personalised cooling protocol
4 secondary outcomes
Energy expenditure
Time frame: 1 day
Body core temperature
Time frame: 1 day
Skin temperatures
Time frame: 1 day
Skin perfusion
Time frame: 1 day
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 21 Jul 2015.
- Background: PubMed 15010446Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
- Background: PubMed 19357405van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
- Background: PubMed 19357407Virtanen KA, Lidell ME, Orava J, Heglind M, Westergren R, Niemi T, Taittonen M, Laine J, Savisto NJ, Enerback S, Nuutila P. Functional brown adipose tissue in healthy adults. N Engl J Med. 2009 Apr 9;360(15):1518-25. doi: 10.1056/NEJMoa0808949.
- Background: PubMed 14715917Cannon B, Nedergaard J. Brown adipose tissue: function and physiological significance. Physiol Rev. 2004 Jan;84(1):277-359. doi: 10.1152/physrev.00015.2003.
- Background: PubMed 19401428Saito M, Okamatsu-Ogura Y, Matsushita M, Watanabe K, Yoneshiro T, Nio-Kobayashi J, Iwanaga T, Miyagawa M, Kameya T, Nakada K, Kawai Y, Tsujisaki M. High incidence of metabolically active brown adipose tissue in healthy adult humans: effects of cold exposure and adiposity. Diabetes. 2009 Jul;58(7):1526-31. doi: 10.2337/db09-0530. Epub 2009 Apr 28.
- Background: PubMed 21803297Orava J, Nuutila P, Lidell ME, Oikonen V, Noponen T, Viljanen T, Scheinin M, Taittonen M, Niemi T, Enerback S, Virtanen KA. Different metabolic responses of human brown adipose tissue to activation by cold and insulin. Cell Metab. 2011 Aug 3;14(2):272-9. doi: 10.1016/j.cmet.2011.06.012.
- Background: PubMed 23867626van der Lans AA, Hoeks J, Brans B, Vijgen GH, Visser MG, Vosselman MJ, Hansen J, Jorgensen JA, Wu J, Mottaghy FM, Schrauwen P, van Marken Lichtenbelt WD. Cold acclimation recruits human brown fat and increases nonshivering thermogenesis. J Clin Invest. 2013 Aug;123(8):3395-403. doi: 10.1172/JCI68993. Epub 2013 Jul 15.
- Background: PubMed 13919771TATA JR, ERNSTER L, LINDBERG O. Control of basal metabolic rate by thyroid hormones and cellular function. Nature. 1962 Mar 17;193:1058-60. doi: 10.1038/1931058a0. No abstract available.
- Background: PubMed 12418548Goglia F, Silvestri E, Lanni A. Thyroid hormones and mitochondria. Biosci Rep. 2002 Feb;22(1):17-32. doi: 10.1023/a:1016056905347.
- Background: PubMed 11844744Bianco AC, Salvatore D, Gereben B, Berry MJ, Larsen PR. Biochemistry, cellular and molecular biology, and physiological roles of the iodothyronine selenodeiodinases. Endocr Rev. 2002 Feb;23(1):38-89. doi: 10.1210/edrv.23.1.0455.
- Background: PubMed 22844412Johannsen DL, Galgani JE, Johannsen NM, Zhang Z, Covington JD, Ravussin E. Effect of short-term thyroxine administration on energy metabolism and mitochondrial efficiency in humans. PLoS One. 2012;7(7):e40837. doi: 10.1371/journal.pone.0040837. Epub 2012 Jul 26.
- Background: PubMed 22075692Lee JY, Takahashi N, Yasubuchi M, Kim YI, Hashizaki H, Kim MJ, Sakamoto T, Goto T, Kawada T. Triiodothyronine induces UCP-1 expression and mitochondrial biogenesis in human adipocytes. Am J Physiol Cell Physiol. 2012 Jan 15;302(2):C463-72. doi: 10.1152/ajpcell.00010.2011. Epub 2011 Nov 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.
Wouter van Marken Lichtenbelt, Professor principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxine therapy (137.75 ± 23.75 μg/day) in people with Hypothyroidism and Hyperthyroidism, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 8 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 21 Jul 2015. 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 Netherlands. 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?
Cold-induced brown adipose tissue activity (time frame: 1 day). 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 NCT02499471, which also lists 36 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 21 Jul 2015.