Stem cells in subclinical hypothyroidism
| ISRCTN | ISRCTN70334066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70334066 |
| Protocol serial number | 05/Q090/104 |
| Sponsor | Gateshead Health NHS Foundation Trust (UK) |
| Funder | Gateshead NHS R and D and Gateshead Diabetes Research Charitable Fund (UK) |
- Submission date
- 09/09/2009
- Registration date
- 16/09/2009
- Last edited
- 05/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jolanta Weaver
Scientific
Scientific
Newcastle University
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
| Phone | +44 (0)191 445 2181 |
|---|---|
| J.U.Weaver@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional open-label single-arm trial |
| Secondary study design | Other |
| Study type | Participant information sheet |
| Scientific title | The role of circulating endothelial progenitor cells in relation to endothelial dysfunction in subclinical and overt hypothyroidism |
| Study objectives | The number of circulating endothelial progenitor cells is reduced in subclinical and overt hypothyroidism. The circulating endothelial progenitor cells in subclinical and overt hypothyroidism can be improved after thyroxine therapy. |
| Ethics approval(s) | Gateshead and South Tyneside Local Research Ethics Committee, approved on 12/03/2007 (ref: 05/Q0901/104) |
| Health condition(s) or problem(s) studied | Hypothyroidism |
| Intervention | Thyroxine dose 100 mcg (open label tablet) per day, dose adjusted if required. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thyroxine |
| Primary outcome measure(s) |
Number and function of endothelial progenitor cells. |
| Key secondary outcome measure(s) |
Flow mediated dilatation. |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Both males and females, age less than 70 2. Patients with confirmed subclinical hypothyroidism (thyroid-stimulating hormone [TSH]<10 mU/L) and overt hypothyroidism (TSH>10 mU/L) |
| Key exclusion criteria | 1. Treatment for thyroid conditions 2. Known cardiovascular disease or risk factors |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Newcastle University
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2010 | Yes | No | |
| Results article | subclinical thyrotoxicosis and cardiovascular risk results | 18/07/2022 | 05/08/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/08/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2010 reference.
