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Trial record 2 of 3 for:    19357407 [PUBMED-IDS]

Brown Adipose Tissue Activity and Thyroid Hormone

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ClinicalTrials.gov Identifier: NCT02499471
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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).

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For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will take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).


Condition or disease Intervention/treatment Phase
Hypothyroidism Hyperthyroidism Obesity Other: Levothyroxine therapy (137.75 ± 23.75 μg/day) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brown Adipose Tissue Activity and Thyroid Hormone
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Before levothyroxine therapy 137.75 μg
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.
Other: 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).

After levothyroxine therapy 137.75 μg
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)
Other: 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).




Primary Outcome Measures :
  1. Cold-induced brown adipose tissue activity [ Time Frame: 1 day ]
    Measured with 18FDG PET/CT scan after personalised cooling protocol


Secondary Outcome Measures :
  1. Energy expenditure [ Time Frame: 1 day ]
    Energy expenditure measured with ventilated hood system

  2. Body core temperature [ Time Frame: 1 day ]
    Body core temperature measured with CorTemp telemetric pill

  3. Skin temperatures [ Time Frame: 1 day ]
    Skin temperatures measured with iButton wireless dataloggers at 14 ISO-defined positions on the skin

  4. Skin perfusion [ Time Frame: 1 day ]
    Skin perfusion measured with laser-doppler flowmetry on hand and forearm



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499471


Locations
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Netherlands
Maastricht UMC
Maastricht, Limburg, Netherlands, 6229HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Wouter van Marken Lichtenbelt, Professor Maastricht University Medical Center

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02499471     History of Changes
Other Study ID Numbers: NL 39146.068.11
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Hypothyroidism
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs