The prevalence of growth hormone deficiency in autoimmune thyroid disease

ISRCTN	ISRCTN57632130
DOI	https://doi.org/10.1186/ISRCTN57632130
Secondary identifying numbers	NTR755

Submission date: 22/11/2006
Registration date: 22/11/2006
Last edited: 18/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S A Eskes
Scientific

Academic Medical Center (AMC)
Department of Endocrinology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5669111
Email	S.A.Eskes@amc.uva.nl

Study information

Study design	Observational cross-sectional study
Primary study design	Observational
Secondary study design	Cross-section survey
Study setting(s)	Not specified
Study type	Screening
Scientific title
Study objectives	The prevalence of growth hormone deficiency in autoimmune thyroid disease is higher than in the general population. Please note that as of 07/07/2008 the sources of funding section of this trial was updated. For details of this change, please go to the sources of funding section of this record. On 18/07/2008, the interventions section was also updated.
Ethics approval(s)	Ethics approval received from the local medical ethics committee (Medisch Ethische Toetsings Commissie of the Academic Medical Center Amsterdam) on the 15th December 2005 (ref: MEC 05/249)
Health condition(s) or problem(s) studied	Autoimmune hypothyroidism
Intervention	Investigating the prevalence is of growth hormone deficiency in patients with autoimmune hypothyroidism. Added 18/07/2008: Insulin-like growth factor I (IGF-I) values were measured from a blood sample. If the IGF-I value was beneath the 10th percentile of the reference values, a growth-hormone-releasing hormone (GHRH)/growth-hormone-releasing peptide 6 (GHRP-6) test was performed.
Intervention type	Other
Primary outcome measure	Prevalence of growth hormone deficiency in patients with autoimmune hypothyroidism, measured a the first visit and when the second test is necessary at a second visit that is planned a few weeks later.
Secondary outcome measures	Quality of life in patients with autoimmune hypothyroidism with or without growth hormone deficiency.
Overall study start date	01/08/2006
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	600
Key inclusion criteria	1. Autoimmune hypothyroidism 2. Adequate thyroxine treatment 3. Aged between 20 and 70 years old, both men and women
Key exclusion criteria	1. History of hypothalamic or pituitary disease or known growth hormone deficiency 2. Pregnancy 3. Hypothyroidism after treatment for Graves' disease or surgery or radioactive iodine (I131) 4. Major concurrent diseases 5. Use of medications known to interfere with the growth hormone-Insulin-like Growth Factor-I (IGF-1) axis 6. No informed consent 7. Alcohol or drug abuse
Date of first enrolment	01/08/2006
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC),

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Industry

Added as of 07/07/2008:

No information available

Ipsen Pharmaceutica BV (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan