Research with human participants

Overview of medical research in the Netherlands

The role of TSH in the human immune system, a randomized, controlled, trial

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Last updated:

The main objective of this study is to determine the role of TSH in the generation of new T cells by thymopoiesis

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Immunodeficiency syndromes
Study type
Interventional

ID

NL-OMON33266

Source

ToetsingOnline

Brief title

The role of TSH in the human immune system

Condition

  • Immunodeficiency syndromes

Synonym

T cell deficiency

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
T cell reconstitution, Thymus, TSH

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.

Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

Dr. Molewaterplein 50-60
3015 GE Rotterdam
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

Dr. Molewaterplein 50-60
3015 GE Rotterdam
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

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

Study phase :
2
Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
thyrogen
Generic name :
recombinant human thyrotropin
Registration
:
Yes - NL outside intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 20628
Source: Nationaal Trial Register
Title: De rol van het hormoon TSH in het immuunsysteem.

In other registers

Register ID
EudraCT EUCTR2008-001827-76-NL
CCMO NL28134.078.09
OMON NL-OMON20628