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CompletedNCT01588470Updated Dec 6, 2017Results posted

Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

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

Phase
Phase 4
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVES

  1. To quantitate myocardial insulin sensitivity using positron emission tomography (PET) with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects.
  2. To quantitate pericardial fat using magnetic resonance spectroscopy in T2DM and control subjects.
  3. To quantitate cardiac function using magnetic resonance imaging and echocardiography in T2DM and control subjects.
  4. To examine the effect of pioglitazone on myocardial insulin sensitivity, pericardial fat content, and cardiac function.

SECONDARY OBJECTIVES To examine the relationships between myocardial insulin sensitivity, pericardial fat content, and cardiac function.

02

Conditions studied

  • Type 2 Diabetes
  • Coronary Heart Disease

Keywords

  • diastolic function
  • mitochondria
  • pioglitazone
  • pericardial fat
03

In context

Heart Diseases

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  • Patients may be of either sex. Female patients must be non-lactating and must either be at least one year post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period
  • Patients must range in age from 18 to 75 years, inclusive.
  • Patients with type 2 diabetes must be drug naïve, receiving monotherapy with metformin or with a sulfonylurea, or combination therapy with both: metformin \& sulfonylurea.
  • Patients must have the following laboratory values:

    • Hematocrit ≥ 34 vol%
    • Serum creatinine ≤ 1.8 mg/dl
    • AST (SGOT) ≤ 2.5 times upper limit of normal
    • ALT (SGPT) ≤ 2.5 times upper limit of normal
    • Alkaline phosphatase ≤ 2 times upper limit of normal
  • Patients must have been on a stable dose of allowed chronic medications for 30 days prior to entering the study.
  • Only subjects whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

Exclusion criteria

Exclusion Criteria:

  • Patients must not have type 1 diabetes.
  • Patients must not be receiving any medications with known adverse effects on glucose tolerance (except metformin or a sulfonylurea) unless the patient has been on stable doses of such agents for the past three months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy, if the patient has been on these agents for the prior three months. Patients taking systemic glucocorticoids are excluded.
  • Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
  • Patients with hematocrit \< 34% will be excluded.
  • Patient who were exposed to any procedure involves radiation exposure and his total radiation dose equivalent exceeds 5 rem during the past year will be excluded from the study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Pioglitazone

    Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone

    Drug: pioglitazone

Interventions

  • Drugpioglitazone

    45 mg per day for 6 months

    Also known as: Actos

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change in Hemoglobin A1c

    Change in hemoglobin A1c levels measured at 6 months

    Time frame: Baseline and 6-months Post Treatment

07

Results

Posted Dec 6, 2017

Participant flow

Participant flow — Overall Study
MilestonePioglitazone
Started130
Completed50
Not completed80

Outcome measures

PrimaryChange 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
Reported as:
Mean · Ratio
Change in E to A Ratio
RatioBaselineE to A Ratio After Pioglitazone Treatment
Change in E to A Ratio1.04 ± 0.281.25 ± 0.38
Statistical analysis
  • E to A Ratio After Pioglitazone Treatment · ANOVA · p = <0.01
PrimaryMyocardial 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
Reported as:
Mean · uM/min/g
Myocardial Glucose Uptake
uM/min/gBaselinePioglitazone
Myocardial Glucose Uptake0.24 ± 0.140.42 ± 0.13
SecondaryChange in Hemoglobin A1c

Change in hemoglobin A1c levels measured at 6 months

Time frame:
Baseline and 6-months Post Treatment
Reported as:
Mean · percent
Change in Hemoglobin A1c
percentBaselinePioglitazone
Change in Hemoglobin A1c6.7 ± 1.35.6 ± 0.8
Statistical analysis
  • Baseline vs Pioglitazone · ANOVA · p = <0.05 · Mean difference (final values): -1.1

Adverse events

Collected over data were collected over 6 months period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pioglitazone0/130 (0%)0/130 (0%)2/130 (1.5%)
Most frequent other events
Most frequent other events
EventPioglitazone
Mild weight gain ~2kg with ankle edemaVascular disorders2/130

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pioglitazone
<=18 years0
Between 18 and 65 years50
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Pioglitazone
Female10
Male40
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Clarke GD, Solis-Herrera C, Molina-Wilkins M, Martinez S, Merovci A, Cersosimo E, Chilton RJ, Iozzo P, Gastaldelli A, Abdul-Ghani M, DeFronzo RA. Pioglitazone Improves Left Ventricular Diastolic Function in Subjects With Diabetes. Diabetes Care. 2017 Nov;40(11):1530-1536. doi: 10.2337/dc17-0078. Epub 2017 Aug 28. PubMed 28847910 ↗

Individual participant data

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01588470
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Takeda Pharmaceuticals North America, Inc.
Responsible party
Ralph DeFronzo (Professor & Division Chief, Department of Medicine, Division of Diabetes, The University of Texas Health Science Center at San Antonio) — Principal investigator
First posted
May 1, 2012
Start date
Jun 2006
Primary completion
Dec 2011
Completion
Dec 2011
Results posted
Dec 6, 2017
Last update
Dec 6, 2017

Study contacts

Ralph A DeFronzo, MD
principal investigator · University of Texas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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