Contact information
Type
Scientific
Primary contact
Dr Jolanta Weaver
ORCID ID
Contact details
Newcastle University
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 445 2181
J.U.Weaver@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05/Q090/104
Study information
Scientific title
The role of circulating endothelial progenitor cells in relation to endothelial dysfunction in subclinical and overt hypothyroidism
Acronym
Study hypothesis
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
Gateshead and South Tyneside Local Research Ethics Committee, approved on 12/03/2007 (ref: 05/Q0901/104)
Study design
Interventional open-label single-arm trial
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hypothyroidism
Intervention
Thyroxine dose 100 mcg (open label tablet) per day, dose adjusted if required.
Intervention type
Drug
Phase
Not Applicable
Drug names
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 trial start date
01/05/2007
Overall trial end date
30/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Treatment for thyroid conditions
2. Known cardiovascular disease or risk factors
Recruitment start date
01/05/2007
Recruitment end date
30/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle University
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Organisation
Gateshead Health NHS Foundation Trust (UK)
Sponsor details
Sheriff Hill
Gateshead
Tyne and Wear
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 445 2181
J.U.Weaver@ncl.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Gateshead NHS R and D and Gateshead Diabetes Research Charitable Fund (UK)
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19897678
Publication citations
-
Results
Shakoor SK, Aldibbiat A, Ingoe LE, Campbell SC, Sibal L, Shaw J, Home PD, Razvi S, Weaver JU, Endothelial progenitor cells in subclinical hypothyroidism: the effect of thyroid hormone replacement therapy., J. Clin. Endocrinol. Metab., 2010, 95, 1, 319-322, doi: 10.1210/jc.2009-1421.