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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 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For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will take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 and SUV. Secondary endpoints are the effects of thyroid hormone and thyroid-stimulating hormone on energy metabolism, body core temperature, skin surface temperature 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 of 18F-FDG is 2.8 mSv. The routine clinical treatment program requires a I124 PET-CT scan (182mSv) and a I131 ablation therapy (41625 mSv) of possible thyroid gland remnants. The additional radiation dose from measurements in this study is considered low in comparison to the standard radiation dose given for regular therapy.
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Levothyroxine therapy (137.75 ± 23.75 μg/day)
Maastricht University Medical Center
Published on BioPortfolio: 2015-07-17T10:38:24-0400
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