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
Scientific
The Institute of Cardiovascular Research
Department of Medicine
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
| j.j.f.belch@dundee.ac.uk |
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Discovery of novel biomarkers in peripheral arterial disease/metabolic syndrome |
| Study acronym | PAD Wyeth |
| Study objectives | 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(s) | Tayside Ethics Committee, 13/06/2007, ref: 07/S1401/43 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Pioglitazone |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Completion date | 30/06/2008 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 80 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
The Institute of Cardiovascular Research
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
c/o Mr James Houston
Research and Innovation Services
University of Dundee
DD1 4HN
Dundee
DD1 4HN
Scotland
United Kingdom
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
