Type 2 diabetes and peripheral arterial disease Nutritional, Metabolic, Endocrine Type 2 diabetes and peripheral arterial disease
Conditions
Interventions
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. Endotheli
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of new biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed