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
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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
Lack of funding/sponsorship
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
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