To study the effect of thyroid hormone and thyroid-stimulating hormone on brown adipose tissue activity.
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the effect of thyroid hormone and
thyroid-stimulating hormone on BAT activity in kBq and SUV.
Secondary outcome
Secondary endpoints are the effects of thyroid hormone and thyroid-stimulating
hormone on energy metabolism, body composotion, plasma values of thyroid
hormone, body core temperature, skin surface temperature and skin perfusion.
Background summary
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, we set up the following
research protocol. In this protocol BAT activity will be determined in subjects
that underwent thyroidectomy for well-differentiated thyroid carcinoma.
Study 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 burden and risks
The absorbed radiation dose from the FDG PET-CT scan after administration of 74
MBq of 18F-FDG is 2.8 mSv. The 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.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
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
- Psychological 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;
o 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
- Patients that have donated blood in the past 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39146.068.11 |