Effects of Pioglitazone on Platelet Function
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Hematology |
| Therapuetic Areas: | Hematology, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2008 |
| End Date: | June 2011 |
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.
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.
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.
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.
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.
We found this trial at
1
site
University of Rochester The University of Rochester is one of the country's top-tier research universities....
Click here to add this to my saved trials
