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Effects of Pioglitazone on Platelet Function (UHEM08014)

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ClinicalTrials.gov Identifier: NCT00861341
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Charles Francis, University of Rochester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Platelet Function Healthy Drug: Aspirin Drug: Pioglitazone Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effects of Pioglitazone on Platelet Function
Study Start Date : December 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pioglitazone with or without 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.
 Drug: Aspirin
81 mg

Drug: Pioglitazone
30mg Pioglitazone x1
Other Name: Actos


Outcome Measures
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Primary Outcome Measures :
  1. Percent Platelet Aggregation Induced by Arachidonic Acid [ Time Frame: at baseline and days 6-9 ]
    Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using arachidonic acid (0.5 mM). At each time point the results are shown for maximum percent aggregation with arachidonic acid for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6-9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.

  2. Percent Platelet Aggregation Induced by Collagen [ Time Frame: baseline and day 6-9 ]
    Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using collagen (2ug.mL). At each time point the results are shown for maximum percent aggregation with collagen for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6-9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861341


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Charles W Francis, MD University of Rochester
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Charles Francis, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00861341    
Other Study ID Numbers: 24695
First Posted: March 13, 2009    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016
Last Verified: December 2015
Keywords provided by Charles Francis, University of Rochester:
Pioglitazone
Thiazolidinediones
Platelet Function
 Platelet aggregation
Diabetic
Aspirin.
Additional relevant MeSH terms:
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Aspirin
Pioglitazone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Hypoglycemic Agents