The prevalence of growth hormone deficiency in autoimmune thyroid disease
| ISRCTN | ISRCTN57632130 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57632130 |
| Protocol serial number | NTR755 |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funders | Added as of 07/07/2008:, Ipsen Pharmaceutica BV (The Netherlands) |
- 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
Scientific
Academic Medical Center (AMC)
Department of Endocrinology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| S.A.Eskes@amc.uva.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional study |
| Secondary study design | Cross-section survey |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Quality of life in patients with autoimmune hypothyroidism with or without growth hormone deficiency. |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
