Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/09/2009
Date assigned
16/09/2009
Last edited
02/02/2010
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 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 measures

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

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

http://www.gatesheadhealth.nhs.uk/

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19897678

Publication citations

  1. 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.

Additional files

Editorial Notes