Brown Adipose Tissue Activity and Thyroid Hormone

NCT02499471 | Completed

• 1 other identifier: NL 39146.068.11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 For patients clinically withdrawn from thyroid hormone suppletion, the first occasion will be in a hypothyroid state within 4-6 weeks after thyroidectomy and the second measurement will take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

Conditions

Hypothyroidism; Hyperthyroidism; Obesity

Outcome Measures

Primary Outcomes (1)

• Cold-induced brown adipose tissue activity

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

  1 day

Secondary Outcomes (4)

• Energy expenditure

  1 day

• Body core temperature

  1 day

• Skin temperatures

  1 day

• Skin perfusion

  1 day

Study Arms (2)

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.

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)

Other: Levothyroxine therapy (137.75 ± 23.75 μg/day)

Interventions

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).

After levothyroxine therapy 137.75 μg; Before levothyroxine therapy 137.75 μg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6229HX, Netherlands

Location

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MeSH Terms

Conditions

Hypothyroidism; Hyperthyroidism; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Wouter van Marken Lichtenbelt, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 16, 2015
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2014
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

NL (1)