Trial Outcomes & Findings for Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM) (NCT NCT01588470)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

130 participants

Primary outcome timeframe

Baseline and 6-months Post Treatment

Results posted on

2017-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Pioglitazone Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone pioglitazone : 45 mg per day for 6 months
Overall Study STARTED	130
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	80

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone n=50 Participants Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone pioglitazone: 45 mg per day for 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6-months Post Treatment

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.

Outcome measures

Outcome measures
Measure	Baseline n=130 Participants Measure of E to A Ratio to determine which subjects will receive pioglitazone: 45 mg per day for 6 months	E to A Ratio After Pioglitazone Treatment n=50 Participants Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone pioglitazone: 45 mg per day for 6 months
Change in E to A Ratio	1.04 Ratio Standard Deviation 0.28	1.25 Ratio Standard Deviation 0.38

PRIMARY outcome

Timeframe: Baseline and 6-months Post Treatment

Population: Study participants who met eligibility criteria

Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone

Outcome measures

Outcome measures
Measure	Baseline n=130 Participants Measure of E to A Ratio to determine which subjects will receive pioglitazone: 45 mg per day for 6 months	E to A Ratio After Pioglitazone Treatment n=24 Participants Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone pioglitazone: 45 mg per day for 6 months
Myocardial Glucose Uptake	0.24 uM/min/g Standard Deviation 0.14	0.42 uM/min/g Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline and 6-months Post Treatment

Population: Enrolled subjects that meet eligibility criteria as type 2 diabetics or non diabetic subjects with coronary heart disease

Change in hemoglobin A1c levels measured at 6 months

Outcome measures

Outcome measures
Measure	Baseline n=130 Participants Measure of E to A Ratio to determine which subjects will receive pioglitazone: 45 mg per day for 6 months	E to A Ratio After Pioglitazone Treatment n=12 Participants Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone pioglitazone: 45 mg per day for 6 months
Change in Hemoglobin A1c	6.7 percent Standard Deviation 1.3	5.6 percent Standard Deviation 0.8

Adverse Events

Pioglitazone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pioglitazone n=130 participants at risk Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone pioglitazone: 45 mg per day for 6 months
Vascular disorders Mild weight gain ~2kg with ankle edema	1.5% 2/130 • Number of events 2 • data were collected over 6 months period

Additional Information

Dr. Muhammad Abdul-Ghani, MD

UT Health Science, San Antonio

Phone: 210-567-6691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place