A Phase 4 interventional study of pioglitazone in Type 2 Diabetes and Coronary Heart Disease, sponsored by The University of Texas Health Science Center at San Antonio. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment
The purpose of this study is to examine the existence of heart abnormalities in patients with diabetes and the effect of pioglitazone in correcting these abnormalities.
PRIMARY OBJECTIVES
SECONDARY OBJECTIVES To examine the relationships between myocardial insulin sensitivity, pericardial fat content, and cardiac function.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 130 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have the following laboratory values:
Exclusion Criteria:
Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone
Drug: pioglitazone
45 mg per day for 6 months
Also known as: Actos
Change in E to A Ratio
The E to A ratio is a marker of the function of the left ventricle of the heart. It represents the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by the atrial contraction (the A wave) This is measured using ultrasound-based cardiac imaging. In a healthy heart the E velocity is greater than the A velocity.
Time frame: Baseline and 6-months Post Treatment
Myocardial Glucose Uptake
Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone
Time frame: Baseline and 6-months Post Treatment
Change in Hemoglobin A1c
Change in hemoglobin A1c levels measured at 6 months
Time frame: Baseline and 6-months Post Treatment
| Milestone | Pioglitazone |
|---|---|
| Started | 130 |
| Completed | 50 |
| Not completed | 80 |
The E to A ratio is a marker of the function of the left ventricle of the heart. It represents the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by the atrial contraction (the A wave) This is measured using ultrasound-based cardiac imaging. In a healthy heart the E velocity is greater than the A velocity.
| Ratio | Baseline | E to A Ratio After Pioglitazone Treatment |
|---|---|---|
| Change in E to A Ratio | 1.04 ± 0.28 | 1.25 ± 0.38 |
Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone
| uM/min/g | Baseline | Pioglitazone |
|---|---|---|
| Myocardial Glucose Uptake | 0.24 ± 0.14 | 0.42 ± 0.13 |
Change in hemoglobin A1c levels measured at 6 months
| percent | Baseline | Pioglitazone |
|---|---|---|
| Change in Hemoglobin A1c | 6.7 ± 1.3 | 5.6 ± 0.8 |
Collected over data were collected over 6 months period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pioglitazone | 0/130 (0%) | 0/130 (0%) | 2/130 (1.5%) |
| Event | Pioglitazone |
|---|---|
| Mild weight gain ~2kg with ankle edemaVascular disorders | 2/130 |
| Age, Categorical(Participants) | Pioglitazone |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 50 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Pioglitazone |
|---|---|
| Female | 10 |
| Male | 40 |
No study locations are listed for this record.
Plan to share: No — IPD data will not be available for other researchers. However, a manuscript describing the study results is under review for publication in the medical literature
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio