Stem cells in subclinical hypothyroidism

ISRCTN	ISRCTN70334066
DOI	https://doi.org/10.1186/ISRCTN70334066
Secondary identifying numbers	05/Q090/104

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

Newcastle University
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Phone	+44 (0)191 445 2181
Email	J.U.Weaver@ncl.ac.uk

Study information

Study design	Interventional open-label single-arm trial
Primary study design	Interventional
Secondary study design	Other
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Thyroxine
Primary outcome measure	Number and function of endothelial progenitor cells. All outcomes will be assessed before and after thyroxine therapy (being stable for 3 months on therapy).
Secondary outcome measures	Flow mediated dilatation. All outcomes will be assessed before and after thyroxine therapy (being stable for 3 months on therapy).
Overall study start date	01/05/2007
Completion date	30/11/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Newcastle University

Gateshead
NE9 6SX
United Kingdom

Sponsor information

Gateshead Health NHS Foundation Trust (UK)
Hospital/treatment centre

Sheriff Hill
Gateshead
Tyne and Wear
Gateshead
NE9 6SX
England
United Kingdom

Phone	+44 (0)191 445 2181
Email	J.U.Weaver@ncl.ac.uk
Website	http://www.gatesheadhealth.nhs.uk/
"ROR"	https://ror.org/01aye5y64

Funders

Funder type

Government

Gateshead NHS R and D and Gateshead Diabetes Research Charitable Fund (UK)

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	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

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.