Discovery of novel biomarkers in peripheral arterial disease/metabolic syndrome

ISRCTN ISRCTN46806801
DOI https://doi.org/10.1186/ISRCTN46806801
Secondary identifying numbers PADBelch07
Submission date
28/03/2007
Registration date
19/06/2007
Last edited
21/06/2017
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jill Belch
Scientific

The Institute of Cardiovascular Research
Department of Medicine
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Email j.j.f.belch@dundee.ac.uk

Study information

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDiscovery of novel biomarkers in peripheral arterial disease/metabolic syndrome
Study acronymPAD Wyeth
Study objectivesThe 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(s)Tayside Ethics Committee, 13/06/2007, ref: 07/S1401/43
Health condition(s) or problem(s) studiedType 2 diabetes and peripheral arterial disease
InterventionIn 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Pioglitazone
Primary outcome measureDevelopment of new biomarkers
Secondary outcome measuresCorrelate 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 study start date01/04/2007
Completion date30/06/2008
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants80
Key inclusion criteriaFor 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.
Key exclusion criteria1. 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
Date of first enrolment01/04/2007
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

The Institute of Cardiovascular Research
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

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

ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Industry

Wyeth Pharmaceuticals (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

21/06/2017: Trial has been abandoned due to funding failure.
14/06/2017: No publications found in PubMed, verifying study status with principal investigator.