Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/03/2007
Date assigned
19/06/2007
Last edited
17/02/2015
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

Prof Jill Belch

ORCID ID

Contact details

The Institute of Cardiovascular Research
Department of Medicine
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
-
j.j.f.belch@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PADBelch07

Study information

Scientific title

Discovery of novel biomarkers in peripheral arterial disease/metabolic syndrome

Acronym

PAD Wyeth

Study hypothesis

The overall objective of the research proposal is to determine the occurrence of biomarkers with proven links to future cardiovascular events in patients with Peripheral Arterial Disease (PAD) and type 2 diabetes receiving various standards of care medicines including pioglitazone.

On 21/06/2007 the target number of participants was changed from 70 to 80.

Ethics approval

Tayside Ethics Committee, 13/06/2007, ref: 07/S1401/43

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes and peripheral arterial disease

Intervention

In the Phase 1 section of this trial, blood and urine samples will be collected for the following analyses:
1.Transcriptional analysis
2. Other assays:
2.1. E selectin
2.2. P selectin
2.3. Endothelin
2.4. C-Reactive Protein (CRP)
2.5. Isoprostanes
2.6. Intercellular Adhesion Molecules (ICAM)

Laser Doppler imaging and iontophoresisces will also be performed, as well as measuring the flow mediated dilatation and arterial stiffness using the SphygmoCor pulse wave analysis system and Intima-Media Thickness.

In the Phase 2 section of this trial either 45 mg pioglitazone (orally) or a placebo will be given for 30 days to study its effect on vascular behaviour.

Intervention type

Drug

Phase

Not Applicable

Drug names

Pioglitazone

Primary outcome measures

Development of new biomarkers

Secondary outcome measures

Correlate clinical parameters (e.g. walking distances) in patients with PAD and type 2 diabetes treated with various standard of care medicines to genes and protein profiling in muscle biopsies.

Overall trial start date

01/04/2007

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

For Phase 1 study subjects with PAD and type 2 diabetes will be included. PAD will be defined as patients with classical symptoms of intermittent claudication plus an Ankle brachial Blood Pressure Index (ABPI) of <0.9, the accepted cut off level for such a diagnosis.

For Phase 2 study patients with short distance claudication (<200 yards) will be selected for the walking study, as their walking distances are more reproducible (i.e. using the standardized Gardner walking treadmill protocol no more than 25% variation from 2 consecutive treadmill tests performed at least a week apart during the screening period). Patients for this second study will be type 2 diabetic patients not receiving insulin.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Contraindication to thiazolidinedione group of drugs
2. Subjects taking sulphonylureas
3. Subjects with cardiovascular disease event within last three months (such as Myocardial Infarction [MI], unstable angina and stroke)
4. For Phase 2 study, subjects having more than 25% variation from 2 consecutive treadmill tests performed at least a week apart

Recruitment start date

01/04/2007

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Institute of Cardiovascular Research
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

c/o Mr James Houston
Research and Innovation Services
University of Dundee
DD1 4HN
Dundee
DD1 4HN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Wyeth Pharmaceuticals (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