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Type 2 Diabetes MellitusPhase 1NCT00232362

Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus

A Phase 1 study testing Pioglitazone (Actos) and Anti-diabetic agent other than pioglitazone or rosiglitazone in people with Type 2 Diabetes Mellitus, run by Texas Tech University Health Sciences Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is being done to determine if pioglitazone (Actos) is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabetic patients. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Pioglitazone (Actos) and Anti-diabetic agent other than pioglitazone or rosiglitazone
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2007to Jun 2008
Phase
Phase 1
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes mellitus (DM)
  • Ages 18 to 65 years old
  • Patients with left ventricular diastolic dysfunction (LVDD) and ejection fraction (EF) > 50%

Who cannot join

  • Patients with uncontrolled hypertension
  • Patients with active myocardial ischemia with Canadian Cardiovascular Society (CCS) > II or known coronary artery disease (CAD)
  • Patients with atrial fibrillation
  • Patients with systolic heart failure
  • Patients with mitral regurgitation grade 2 or more
  • Patients with restrictive cardiomyopathy
Show all 17Show fewer
  • Patients with constrictive pericarditis
  • Pregnant female patients
  • Recent stroke
  • Sepsis
  • Liver enzymes more than 2.5 times the normal
  • Hemoglobin < 11g/dl or hematocrit < 30%
  • Terminal cancer
  • Patients on fibrates group of lipid lowering agents
  • Patients already on pioglitazone or rosiglitazone
  • Patients who are placed in the control group may not be currently taking a medication in the glitazones drug class.
  • Current or prior use of Pioglitazone or Rosiglitazone within the preceding 6 months.

About this study

This study is being done to determine if pioglitazone (Actos) is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabetic patients.

Read the detailed description

Cross sectional and population-based studies indicate that at least one third of all patients with congestive heart failure (CHF) have a normal or near normal ejection fraction, which is thought to be secondary to diastolic dysfunction or failure. The mortality rates among the patients with diastolic failure ranges from 5-8% annually, as compared with 10-15% among patients with systolic heart failure. The morbidity associated with diastolic heart failure is similar to that of systolic heart failure. Several studies have shown that even simple Doppler evidence of diastolic dysfunction is an independent risk factor for the development of CHF and cardiac death and increased all cause mortality. Several studies indicate that left ventricular diastolic dysfunction (LVDD) represent the earliest preclinical manifestation of diabetic cardiomyopathy that can progress to symptomatic heart failure. Recent studies have demonstrated up to 60% of asymptomatic, normotensive patients with type 2 diabetes have LVDD when assessed by conventional echocardiography including the response to the Valsalva maneuver. A recent study using conventional Doppler, valsalva maneuver, color M-mode echocardiography and tissue doppler imaging assessed the diastolic dysfunction in asymptomatic normotensive patients with diabetes mellitus and found diastolic dysfunction in about 75% of these patients. Cardiovascular disease is the leading cause of death in patients with type 2 diabetes mellitus. Although diabetic patients have a large number of cardiovascular risk factors, like hyperlipidemia and hypertension, the diabetic cardiomyopathy occurs independent of these risk factors. Recently animal models have shown that LVDD may be prevented by chronic treatment with peroxisome-proliferator-activated receptors gamma (PPAR) agonists, like thiazolidinediones, in type 2 diabetic rats. Thiazolidinediones act through PPAR, but the exact mechanism by which they improve LVDD is not known. With this background knowledge, we wanted to study the effect of Pioglitazone, which is PPAR agonist and partial PPAR agonist, on the left ventricular diastolic dysfunction in type 2 diabetic human subjects, which has not been studied so far. If this therapy proves to have beneficial effect on the LVDD it will help in preventing the deleterious consequences of diastolic dysfunction in diabetic patients.

Being tested
Pioglitazone (Actos), Anti-diabetic agent other than pioglitazone or rosiglitazone
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Pioglitazone (Actos)Drug

  • Anti-diabetic agent other than pioglitazone or rosiglitazoneDrug

What is being measured

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

  1. Improvement in diastolic function parameters: early peak to late peak velocity (E/A) ratio

  2. deceleration time (DT)

  3. isovolumic relaxation time (IVRT)

  4. E/A ratio percent change with Valsalva maneuver more than 40%

  5. annular tissue Doppler velocity

Timeline

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

  1. First posted4 Oct 2005 (estimated)
  2. Study startJun 2007
  3. Study completionJun 2008 (estimated)

Why it stopped: This study was not conducted as the Principal Investigator left the institution

Resources

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 1
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00232362
Sponsor's protocol ID
L05-115
Status last verified
Apr 2015
First submitted
30 Sep 2005
Last updated
13 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pioglitazone (Actos) and Anti-diabetic agent other than pioglitazone or rosiglitazone in people with Type 2 Diabetes Mellitus, run by Texas Tech University Health Sciences Center.

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 3 inclusion and 17 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: withdrawn, as of the sponsor's last update on 13 Apr 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Improvement in diastolic function parameters: early peak to late peak velocity (E/A) ratio. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Apr 2015; AzTrials last refreshed its copy on 3 Nov 2026.

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