Type 2 DiabetesPhase 4NCT01588470

Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM)

A Phase 4 study testing pioglitazone in people with Type 2 Diabetes and Coronary Heart Disease, run by The University of Texas Health Science Center at San Antonio.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes, Coronary Heart Disease
What is being tested?: pioglitazone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: No sites listed yet
Study dates: Jun 2006to Dec 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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%

Show all 12Show fewer

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.

Who cannot join

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.

About this study

Official title: Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM) - Role of Intramyocellular Lipid Content and Mitochondrial Dysfunction in Myocardial Insulin Resistance and Their Correction With Pioglitazone

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

To quantitate myocardial insulin sensitivity using positron emission tomography (PET) with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects.
To quantitate pericardial fat using magnetic resonance spectroscopy in T2DM and control subjects.
To quantitate cardiac function using magnetic resonance imaging and echocardiography in T2DM and control subjects.
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.

Conditions: Type 2 Diabetes, Coronary Heart Disease
Being tested: pioglitazone
Keywords: diastolic function, mitochondria, pioglitazone, pericardial fat
Medical subject headings: Diabetes Mellitus, Type 2, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pioglitazoneDrug
Also called Actos
45 mg per day for 6 months

Study groups in NCT01588470
Study group	Role	What they receive
Pioglitazone	Experimental	Only subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone Receives: Drug: pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: Baseline and 6-months Post Treatment

Secondary outcomes (1)

Change in Hemoglobin A1c
Change in hemoglobin A1c levels measured at 6 months
Measured: Baseline and 6-months Post Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Dec 2011

First posted1 May 2012 (estimated)
Study startJun 2006
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: this study includes single arm intervention with pioglitazone. T2DM individuals will be studied at baseline and after 6 months treatment. as a reference group, healthy subjects will be studied in cross sectional fashion. Because healthy subjects will not be treated nor restudied at 6 months, they can not be considered a separate arm in the study but rather a reference group
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588470
Sponsor's protocol ID: MM20060280
Other IDs: T001
Status last verified: Oct 2017
First submitted: 19 Mar 2012
Last updated: 6 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Myocardial Dysfunction in Type 2 Diabetes Mellitus (T2DM) - Role of Intramyocellular Lipid Content and Mitochondrial Dysfunction in Myocardial Insulin Resistance and Their Correction With Pioglitazone
ClinicalTrials.gov ID: NCT01588470
Acronym / sponsor ID: MM20060280
Conditions: Type 2 Diabetes, Coronary Heart Disease
Keywords: diastolic function, mitochondria, pioglitazone, pericardial fat
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Collaborators: Takeda Pharmaceuticals North America, Inc.
Study start: Jun 2006
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 1 May 2012 (estimated)
Results: Posted 6 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

PRIMARY OBJECTIVES

To quantitate myocardial insulin sensitivity using positron emission tomography (PET) with 18F-deoxyglucose in type 2 diabetes mellitus (T2DM) and control subjects.
To quantitate pericardial fat using magnetic resonance spectroscopy in T2DM and control subjects.
To quantitate cardiac function using magnetic resonance imaging and echocardiography in T2DM and control subjects.
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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: this study includes single arm intervention with pioglitazone. T2DM individuals will be studied at baseline and after 6 months treatment. as a reference group, healthy subjects will be studied in cross sectional fashion. Because healthy subjects will not be treated nor restudied at 6 months, they can not be considered a separate arm in the study but rather a reference group

Arm	Type	Receives
Pioglitazone	Experimental	Drug: pioglitazoneOnly subjects with T2DM or non-diabetic subjects with coronary heart disease will receive Pioglitazone

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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:

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pioglitazoneAlso: Actos45 mg per day for 6 months	Drug	Pioglitazone

Primary outcome

Change in E to A Ratio
Time frame: 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.
Myocardial Glucose Uptake
Time frame: Baseline and 6-months Post Treatment
Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone

1 secondary outcome

Change in Hemoglobin A1c
Time frame: Baseline and 6-months Post Treatment

Results and safety

Results posted to the registry on 6 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pioglitazone	130	50

Primary outcome: Change in E to A Ratio

Time frame: Baseline and 6-months Post Treatment. Mean (Standard Deviation). Unit: Ratio

Measure	Baseline n = 130	E to A Ratio After Pioglitazone Treatment n = 50
Value	1.04 (0.28)	1.25 (0.38)

E to A Ratio After Pioglitazone Treatment: p <0.01, ANOVA

Primary outcome: Myocardial Glucose Uptake

Time frame: Baseline and 6-months Post Treatment. Mean (Standard Deviation). Unit: uM/min/g

Measure	Baseline n = 130	Pioglitazone n = 24
Value	0.24 (0.14)	0.42 (0.13)

Population analysed: Study participants who met eligibility criteria

1 secondary outcome is reported in the full results.

Adverse events

Time frame: data were collected over 6 months period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone	0 of 130 (0%)	2 of 130 (1.5%)	0 of 130

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28847910Clarke 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.
Individual participant dataSharing planned: 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

Related trials for Type 2 Diabetes

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ralph A DeFronzo, MD principal investigator

University of Texas

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pioglitazone in people with Type 2 Diabetes and Coronary Heart Disease, run by The University of Texas Health Science Center at San Antonio.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in E to A Ratio (time frame: Baseline and 6-months Post Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01588470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.