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Clinical Trials/EUCTR2007-001800-20-GB
EUCTR2007-001800-20-GB
Active, not recruiting
Not Applicable

A randomised, placebo-controlled trial of the effect of pioglitazone on vascular endothelial function and novel biomarkers for macrovascular events in diabetics with established peripheral arterial disease - PAD and Pioglitazone Study

niversity of Dundee0 sitesJune 26, 2007
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ConditionsThe 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.
DrugsActos

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
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.
Sponsor
niversity of Dundee
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 26, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Dundee

Eligibility 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 \<0\.9, the accepted cut off level for such a diagnosis.
  • •We are amending our inclusion criteria and will also be including patients with toe\-brachial pressure index (TBI) of \<0\.70\. This measurement will be used in patients who have high ABPI \>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 (\<200yards) will be selected for the walking study , as their walking distances are more reproducible, ( ie 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 2nd study will be type 2 diabetic patients not receiving insulin.
  • •Are the trial subjects under 18?
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

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.

Outcomes

Primary Outcomes

Not specified

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