The main objective of this study is to determine the role of TSH in the generation of new T cells by thymopoiesis
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints of the study are a change in cell numbers or ratio*s of
peripheral T cell subpopulations and changes in thymic output measured by naïve
T cells and TREC analysis.
Secondary outcome
The secundary endpoints of the study are changes in lipid and bone metabolism,
CK levels and metabolomics
Background summary
TSH stimulates differentiation and inhibits cell death of thymocytes in vitro,
in a fetal thymic organ culture. Therefore TSH could be a previously
unrecognized growth and/or survival factor for thymocytes. In this study we
want to further investigate the role of TSH in T-cell development in vivo
Study objective
The main objective of this study is to determine the role of TSH in the
generation of new T cells by thymopoiesis
Study design
The study is a single center clinical trial
Intervention
Patients will receive 0.3mg rhTSH i.m. twice a week for 3 weeks
Study burden and risks
Increased TSH levels in hypothyroid patients and treatment of patient with
thyroid cancer with recombinant TSH do not result in severe morbidity.
Dr. Molewaterplein 50-60
3015 GE Rotterdam
NL
Dr. Molewaterplein 50-60
3015 GE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
hypothyroidism for the last 6 months with only thyroxin substitution therapy
T3, T4 and TSH blood levels within the normal range for the past 6 months
TSH>20 mU/l at diagnosis
Presence of anti TPO antibodies
Age 20-45 years
Exclusion criteria
Uncontrolled hypothyroidism
Presence of antibodies to the TSH receptor
History of M. Graves or thyroiditis
Presence of struma or an enlarged tyroid gland measured with ultrasound
Serious infections in the last 3 months
Thymectomy in the medical history
T cell affecting co-medication
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2008-001827-76-NL |
CCMO | NL28134.078.09 |
OMON | NL-OMON20628 |