Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/09/2016
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 Rob Andrews

ORCID ID

Contact details

University of Bristol
Department of Exercise and Health Sciences
Tyndall Avenue
Bristol
BS8 1TP
United Kingdom
+44 (0)1823 344988
rob.andrews@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0249142478

Study information

Scientific title

A randomised controlled trial to investigate the effect of regular moderate intensity exercise on plasma fibrinogen in people with type two diabetes: a pilot study

Acronym

Study hypothesis

Does moderate intensity exercise modify plasma fibrinogen levels in people with type two diabetes?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Type two diabetes

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Plasma fibrinogen
2. Plasminogen activator inhibitor-1 (PAI-1)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2003

Overall trial end date

06/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

80 patients with type two diabetes

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Smokers
2. Taking drugs affecting clotting
3. Inability to exercise

Recruitment start date

01/06/2003

Recruitment end date

06/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 1TP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Taunton and Somerset Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Publication citations

Additional files

Editorial Notes

12/09/2016: No publications found, verifying study status with principal investigator.