Clinical trial NCT00861341: Effects of Pioglitazone on Platelet Function
Official title: Effects of Pioglitazone on Platelet Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Platelet Function
Healthy
Keywords: Pioglitazone
Thiazolidinediones
Platelet Function
Platelet aggregation
Diabetic
Aspirin.
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects must be over 21 years of age and provide written informed consent.
* Normal subjects must have a BMI \<30 and must not have known cardiovascular disease, Diabetes Mellitus (DM), hyperlipidemia, or hypertension. Diabetic subjects must have previously diagnosed DM.

Exclusion Criteria:

* Subjects will be excluded if they have hypersensitivity to aspirin or pioglitazone, or if they are receiving warfarin or heparin therapy, are pregnant, or have congestive heart failure or hepatic function impairment.
* Subjects must not have taken aspirin or other drugs inhibiting platelet function such as Plavix or non-steroidal anti-inflammatory drugs for 7 days.
* Subjects will be excluded if they have a history of renal failure, severe liver disease, myeloproliferative disease or other conditions that impair platelet function.

Primary outcomes:
measure: Percent Platelet Aggregation Induced by Arachidonic Acid
timeFrame: at baseline and days 6-9
measure: Percent Platelet Aggregation Induced by Collagen
timeFrame: baseline and day 6-9
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Charles W Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mongan J, Mieszczanska HZ, Smith BH, Messing SP, Phipps RP, Francis CW. Pioglitazone inhibits platelet function and potentiates the effects of aspirin: a prospective observation study. Thromb Res. 2012 Jun;129(6):760-4. doi: 10.1016/j.thromres.2011.12.019. Epub 2012 Jan 4.