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Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are:
Either Pioglitazone or Placebo Pioglitazone will be administered during this study in this Type 2 Diabetic population with Heart Failure to examine if there are any beneficial effects on diastolic and systolic function.
Myocardial blood flow (MBF) is measured using a PET scan, then participants will be randomized to pioglitazone or a placebo to examine the effects of the study drug on the effects on the systolic and diastolic function of the heart. In addition, myocardial insulin sensitivity change will be measured as well as myocardial fat content. The ratio of ATP: PCr will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone Administration Group | Active Comparator | Pioglitazone 15mg/day titrated to 30 mg/day at week 2 and to 45 mg/day at week 4 |
|
| Placebo/Control Group | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Participants will be taking Pioglitazone tablets 1/day for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic function | Measurement of change in systolic function of the heart using cardiac MRI | Baseline and 6-months post treatment (approximately 24 weeks) |
| Change in Diastolic function | Measurement of change in diastolic function of the heart using cardiac MRI | Baseline and 6-months post treatment (approximately 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial insulin sensitivity | Measurement of change in Free Plasma Glucose (FPG) in blood plasma | Baseline and 6-months post treatment (approximately 24 weeks) |
| Myocardial fat content | Measurement of change in myocardial fat content |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sivaram Neppala, MD | Contact | 210-358-7200 | neppalas@uthscsa.edu | |
| Andrea Hansis-Diarte, MPH | Contact | 210-567-3208 | Hansisdiarte@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ralph A DeFronzo, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Diabetes Institute/UH | Recruiting | San Antonio | Texas | 78229-3900 | United States |
IPD data will not be available to other researchers.
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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double-blind placebo controlled, randomized clinical trial
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Neither the participant nor the investigator knows what treatment is given
| Placebo | Drug | Placebo for Pioglitazone |
|
|
| Baseline and 6-months post treatment (approximately 24 weeks) |
| PCr:ATP ratio | Measurement of change in PCr:ATP ratio | Baseline and 6-months post treatment (approximately 24 weeks) |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |