NCT00861341

Effects of Pioglitazone on Platelet Function

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine how pioglitazone and aspirin affect platelets in the blood of diabetic and non-diabetic subjects. Platelets are small cells in the blood that help with blood clotting. Pioglitazone is a drug that is used to lower blood sugar and fats by helping the body to use insulin correctly. Pioglitazone is presently used to treat diabetes but has not been approved for non-diabetics. This study will determine whether pioglitazone reduces the activity of platelets in people who are or are not also taking aspirin.

Detailed description

Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.

Conditions

• Diabetes
• Platelet Function
• Healthy

Interventions

Type	Name	Description
DRUG	Aspirin	81 mg
DRUG	Pioglitazone	30mg Pioglitazone x1

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-06-01
• Completion: 2011-06-01
• First posted: 2009-03-13
• Last updated: 2016-02-03
• Results posted: 2016-02-03

Locations

1 site across 1 country: United States