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NCT Number: NCT02499471

Brown Adipose Tissue Activity and Thyroid Hormone

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For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will take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

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Key information

Conditions

Hypothyroidism Body Weight Endocrine System Diseases Hyperthyroidism Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Thyroid Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht UMC

Maastricht, Limburg, 6229HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Cold-induced brown adipose tissue activity

    Time frame: 1 day

    Measured with 18FDG PET/CT scan after personalised cooling protocol

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Jul 16, 2015
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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