Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
18/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes