The study involves patients with type 2 Diabetes and Peripheral Arterial Disease.The overall objective of the research proposal is to determine the occurrence of biomarkers that typify the metabolic syndrome in patients with peripheral vascular diseases.
Conditions
Interventions
Trade Name: Actos
Product Name: Actos
Product Code: Actos
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Pre-Intervention stage of the study subjects with Peripheral Arterial Disease (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 1.1 due to non-compressible arteries. This validated measurement has previously been used in Genzyme WALK study which is an International Gene Therapy trial in PAD patients. There is no clinical contraindication for these patients. This will help us in recruitment. We are also submitting a poster about the study which we will display around the hospital for advertisement of the study. For Intervention stage of the study patients with short distance claudication (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindication to thiazolidinedione group of drugs. 2. Subjects taking Sulphonylureas 3. Subjects with Cardiovascular disease event within last three months like MI, unstable angina, stroke. 4. For Phase 2 study, subjects having more than 25% variation from 2 consecutive treadmill tests performed atleast a week apart.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Pre-Intervention Stage: 1. Identify biomarkers for improved vascular health 2. Transcriptional mRNA profiling of peripheral blood leukocytes from patients with PAD in reference to standard treatment 3. Transcriptional gene and protein profiling in muscle of PAD patients in resting and in exercise Intervention Stage: 4. Correlate clinical parameters (e.g. walking distances) in patients with Peripheral Arterial Disease (PAD) and type 2 diabetes treated with various standard of care medicines to genes and protein profiling in muscle biopsies. ;Main Objective: 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.;Primary end point(s): New biomarkers in PAD | — |
Countries
United Kingdom
Outcome results
None listed