Contact information
Type
Scientific
Primary contact
Dr S A Eskes
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Endocrinology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5669111
S.A.Eskes@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR755
Study information
Scientific title
Acronym
Study hypothesis
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
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)
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/08/2006
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Autoimmune hypothyroidism
2. Adequate thyroxine treatment
3. Aged between 20 and 70 years old, both men and women
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/08/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC),
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Industry
Funder name
Added as of 07/07/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ipsen Pharmaceutica BV (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary