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ISRCTN
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ISRCTN46806801
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ClinicalTrials.gov identifier
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Public title
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Discovery of novel biomarkers in peripheral arterial disease / metabolic syndrome
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Scientific title
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Acronym
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PAD Wyeth
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Serial number at source
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PADBelch07
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Tayside Ethics Committee, approved on 13 June 07 (ref: 07/S1401/43).
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Study design
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Randomised, double-blind, placebo controlled trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Type 2 diabetes and peripheral arterial disease
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2007
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Anticipated end date
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30/06/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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As of 21/06/2007: 80; At time of registration: 70
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Interventions
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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.
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Primary outcome measure(s)
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Development of new biomarkers
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Secondary outcome measure(s)
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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.
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Sources of funding
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Wyeth Pharmaceuticals (UK)
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Trial website
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Publications
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Contact name
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Prof
Jill
Belch
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Address
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The Institute of Cardiovascular Research
Department of Medicine
Ninewells Hospital & Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Email
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j.j.f.belch@dundee.ac.uk
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Sponsor
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University of Dundee (UK)
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Address
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c/o Mr James Houston
Research and Innovation Services
University of Dundee
DD1 4HN
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City/town
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Dundee
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Zip/Postcode
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DD1 4HN
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Country
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United Kingdom
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Date applied
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28/03/2007
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Last edited
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08/02/2012
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Date ISRCTN assigned
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19/06/2007
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