Brown Adipose Tissue Activity and Thyroid Hormone

July 20, 2015 updated by: Maastricht University Medical Center

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For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will take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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229HX
        • Maastricht UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cold-induced brown adipose tissue activity
Time Frame: 1 day
Measured with 18FDG PET/CT scan after personalised cooling protocol
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy expenditure
Time Frame: 1 day
Energy expenditure measured with ventilated hood system
1 day
Body core temperature
Time Frame: 1 day
Body core temperature measured with CorTemp telemetric pill
1 day
Skin temperatures
Time Frame: 1 day
Skin temperatures measured with iButton wireless dataloggers at 14 ISO-defined positions on the skin
1 day
Skin perfusion
Time Frame: 1 day
Skin perfusion measured with laser-doppler flowmetry on hand and forearm
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Wouter van Marken Lichtenbelt, Professor, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL 39146.068.11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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